FDA (Devices) recall action 68536

Customed, Inc recalled 233 products on 2014-09-10

The FDA (Devices) publishes a recall like this one as 233 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 233 pages.

Products: 233
Announced: 2014-09-10
Critical: 26
Units: —

Why these products were recalled

Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

101–125 of 233

HighFDA (Devices)··2014-09-10
Customed Recalls Laparoscopy Premium Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling specific lots of Laparoscopy Premium Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY PREMIUM PACK - (1) TABLE COVER REINFORCED 50" x 90" UF (4) TOWEL ABSORBENT 15" x 20" UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) DRAPE LASER CAMERA W/EL UF (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) (1) APPLIER CLIP 5MM (3) GOWN XLGE SMS IMPERV. REINFORCED (1
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls General Minor Packs Due to Potential Sterility Loss
Customed, Inc. is recalling General Minor Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
GENERAL MINOR PACK- (1) MAYO STAND COVER REINFORCED LIF (2) BOWL UTILITY 16oz LIF (1) TIP CAUTERY POLISHER LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) BOWL UTILITY 32oz (1) BAG SUTURE FLORAL (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (10) GAUZE SPONGES 4" X 4" 16PLY XRD LIF
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls AV Fistula Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling AV Fistula surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCT
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Face Lift Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Face Lift surgical packs (Code 900-3083) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Face Lift , Code 900-3083, contains: (I) SHEET ENT SPLIT 110" X 77" LIF (I) COVER TABLE REINFORCED 50" X 90" LIF (I) DRAPE HEAD WITH TAPE 44" X 26" LIF (I) COVER MAYO STAND REINFORCED LIF (I) BAG SUTURE FLORAL LIF (3) GOWN STANDARD LARGE SMS VEL/NE LABEL SAMPLE (I) COUNTE
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Distribution
2 states
SevereFDA (Devices)··2014-09-10
Customed Recalls Urology Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 440 units of Urology Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION CO
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Orthopedic Implant Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 180 units of Orthopedic Implant Packs (Code 900-2903) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8" X 7.5" (1)
Category
Distribution
2 states
SevereFDA (Devices)··2014-09-10
Customed Recalls Face Pack Aesthetic Surgery Kits Due to Packaging Integrity Concerns
Customed, Inc. is recalling 96 units of Face Pack Aesthetic Surgery kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
FACE PACK AESTHETIC SURGERY AESTHETIC SURGERY CONTENTS: (15) APPLICATOR COTION 6" WOOD (60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF (8) TOWELS CLOTH HUCK BLUE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (6) BLADE #15 CARBO
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 214 units of laparoscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
LAPAROSCOPY PACK CONTENTS: ( I ) BULB SYRINGE 60cc LIF ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF ( I ) MAYO STAND COYER REINFORCED LIF ( I ) TABLE COVER REINFORCED 50" X 90" LIF (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LI
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 1,485 units of EO sterilized surgical packs across 22 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
0.B. PACK - HSCH- (1) PVP SCRUB 8" STICK SPONGES (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" X 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (1) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) BOWL PLASTIC WITH LID 80oz LIF (1) RECEIVING BLANKET 100% COTTON (1) BABY
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Surgical Ear Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 123 units of surgical ear packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P
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Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Surgical Gown Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Gown Surgical Soft SMS Non Reinforced, code 900-2725, contains: (1) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE (1) TOWEL ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Ophthalmic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling ophthalmic surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) OPHTALMIC DRAPE WITH POUCH LIF (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (10) COTTON TIP APPLICATOR 6" WOOD (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 18G
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Orthopedic Pack I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPL
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Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 31 lots of surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
SURGICAL PACK CONTENTS: (1) SUTURE BAG FLORAL (1) WRAPPER 30" X 30" (2) UTILITY BOWL 16oz (1) TRAY ORGANIZER FULL DEEP (1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WITHOUT VENT (5) LAP SPONGE PREWASH 18" X 18" XRD (1) BLADE SURG. #15
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Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 1,305 units of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON REINF
Category
Distribution
2 states
SevereFDA (Devices)··2014-09-10
Customed Recalls Angiodrape Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 180 units of Angiodrape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
ANGIODRAPE PACK - - (1) GUIDEWIRE 0.035" X 150cm (2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK UF (2) Pr. SURGICAL GLOVES #8 (2) GOWN STANDARD LARGE SMS VELCRO NECK (2) NEEDLE HYPODERMIC 21G X 1 W' UF (1) TABLE COVER 44" X 90" (3) CLOTH HUCK TOWELS BLUE (2) UTILITY BOWL 16oz
Category
Distribution
2 states
SevereFDA (Devices)··2014-09-10
Customed Recalls Hip Orthopedic Packs Due to Potential Sterility Loss
Customed, Inc. is recalling 36 units of Hip Orthopedic Packs because packaging integrity may be compromised, risking patient injury from contamination or loss of sterility.
Product
HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WIT APE LIF (4) TOWEL ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling 5,574 units of EO sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Plastic Surgery Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling plastic surgery packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4" X 4" 4PL Y (1) COVER TABLE REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls PHACO PACK Surgical Kits Due to Packaging Integrity Concerns
Customed is recalling 1,775 units of PHACO PACK surgical kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINF
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Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Basic Pack 1 Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Basic Pack 1 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage: E
Category
Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Central Line Drape Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Central Line Drape Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CENTRAL LINE DRAPE PACK 1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free (1) DRAPE SHEET 41" X 58" SMS L/Free (1) CAP NURSE 21" GREEN BOUFFANT (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ FENE (1) WRAPPER 24" X 24" GOWN LGE STANDARD SMS VELCRO NECK TOWELS
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Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Breast Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling specific lots of Breast Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Breast Pack- FJG, code 900-3118, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT~" X 12' (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) BOWL UTIL TIY QUART 32oz (1) COVE
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Distribution
2 states
HighFDA (Devices)··2014-09-10
Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns
Customed, Inc. is recalling Tummy Tuck Pack-BOD surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN MAR
Category
Distribution
2 states
SevereFDA (Devices)··2014-09-10
Customed Recalls Cysto TUR Packs Due to Potential Packaging Integrity Issues
Customed, Inc. is recalling 29 lots of Cysto TUR Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.
Product
CYSTO TUR PACK- - (1) UTILITY BOWL 32oz LIF (1) SPECIMEN CUP WITH CAP 4oz LIF (1 0) GAUZE SPONGE 4" X 4" 12PL Y LIF (4) ABSORBENT TOWELS 15" X 20" LIF (1) CYSTOSCOPY 'T' DRAPE 60" X 87" X 35" SMS STD LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE LIF (2) LEGGINS WITH 7"
Category
Distribution
2 states