FDA (Devices) recall action 71721

Customed, Inc recalled 170 products on 2015-09-09

The FDA (Devices) publishes a recall like this one as 170 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 170 pages.

Products: 170
Announced: 2015-09-09
Critical: 0
Units: 332,934

Why these products were recalled

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–50 of 170

HighFDA (Devices)··2015-09-09
Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 216 units of Cool Impervious XLGE Breathable surgical gowns due to inadequate validation of sterilization processes and package integrity.
Product
GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 490 Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 264 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Recalls Laparoscopy Chole 4/CS Due to Sterilization Validation Issues
Customed, Inc. is recalling specific lots of Laparoscopy Chole 4/CS in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
LAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 304 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Arthroscopy Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 320 Arthroscopy PK 5/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
SevereFDA (Devices)··2015-09-09
Customed O.B. Pack Hospital 3/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Cysto Tur Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 176 units of Cysto Tur Pack Basic due to inadequate validation of sterilization processes and package integrity.
Product
CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Fanfold Drapes Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling Fanfold Drapes due to inadequate validation of sterilization processes and package integrity, posing a potential risk of infection.
Product
FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Recalls Angiodrape Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling Angiodrape Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Product
ANGIODRAPE PACK DAMAS 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Laparoscopy GYN PK CS/4 Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 112 units of Laparoscopy GYN PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY GYN PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Wound Management Tray II Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 690 Wound Management Tray II units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND MANAGEMENT TRAY II 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Wound Closure Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 8,050 Wound Closure Tray I units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Mayo Stand Covers Recalled for Sterilization Process Defects
Customed, Inc. is recalling 540 units of Mayo Stand Covers due to inadequate validation of sterilization processes and package integrity.
Product
MAYO STAND COVER W/CSR WRAP 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Urology Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 352 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Lumbar Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 12 Lumbar Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LUMBAR PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Cysto Tur Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 50 units of Cysto Tur Pack 5/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 75 units of Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PACK 3/Cs Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Urology PK 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Impervious Gowns Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 144 cases of impervious gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
SevereFDA (Devices)··2015-09-09
Customed Cesarean PK 4/CS Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Open Heart Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Open Heart Trays due to inadequate validation of sterilization processes and package integrity.
Product
OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Wound Management Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 580 wound management kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 180 packs of Arthroscopy PK CS/4 kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Distribution
1 state
HighFDA (Devices)··2015-09-09
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 874 C-Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Category
Distribution
1 state