The Recall Desk

FDA (Devices) recall action 71608

EXP Pharmaceutical Services Corp recalled 42 products on 2015-08-05

The FDA (Devices) publishes a recall like this one as 42 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 42 pages.

Products
42
Announced
2015-08-05
Critical
0
Units
174

Why these products were recalled

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were registered and had their own quality systems.

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

1–25 of 42

  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls 3.5mm Threaded Cerclage Pins Due to Registration Failures

    EXP Pharmaceutical Services Corp is recalling 3.5mm Threaded Cerclage Pins because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 298.838S; EXP (repackager), Synthes (OEM) Cerclage, fixation
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging

    EXP Pharmaceutical Services Corp is recalling four units of Trocar VersaPort Plus V2 devices because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 179095P; EXP (repackager), Auto Suture (OEM) Laparoscope, General and Plastic Surgery
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Tracheal Stent Sizing Devices

    EXP Pharmaceutical Services Corp is recalling two units of tracheal stent sizing devices due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Airway Stent Systems

    EXP Pharmaceutical Services Corp is recalling 10x40 Airway Stent Systems because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-209; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Versaport Bladeless Trocar Devices

    EXP Pharmaceutical Services Corp is recalling Versaport Bladeless Trocar devices because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange - Versaport Bladeless Trocar w/ Fixation Cannula 5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number NB5STF; EXP (repackager), Covidien (OEM) Laparoscope, General & Plastic Surgery
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Specimen Retriever Bags Due to Registration Issues

    EXP Pharmaceutical Services Corp is recalling two units of specimen retriever bags because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Stryker Round Fluted Bur Devices

    EXP Pharmaceutical Services Corp is recalling six Stryker Round Fluted Bur devices due to the company's failure to register as a medical device establishment.

    Product
    Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-240; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls SECURESTRAP Absorbable Strap Fixation Devices

    EXP Pharmaceutical Services Corp is recalling SECURESTRAP 5mm Absorbable Strap Fixation Devices because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging

    EXP Pharmaceutical Services Corp is recalling a medical device exchange product because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 38931-04; EXP (repackager), Boston Scientific (OEM) Wire, guide, catheter
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders

    EXP Pharmaceutical Services Corp is recalling 10MM Vascular Transcatheter Septal Occluders because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls 5.5mm BioComposite Corkscrew Suture Anchor Due to Registration Failure

    EXP Pharmaceutical Services Corp is recalling 5.5mm BioComposite Corkscrew Suture Anchors because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture Anchor; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-1927BCF; EXP (repackager), Arthrex (OEM) Fastener, fixation, nondegradable, soft tissue
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls GelPort Laparoscopic Systems for Registration Violations

    EXP Pharmaceutical Services Corp is recalling three GelPort Laparoscopic Systems because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls Unregistered Stryker Femoral Canal Tips

    EXP Pharmaceutical Services Corp is recalling 12 Stryker Femoral Canal Tips because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange FEMORAL CANAL TIP; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 210-8-N; EXP (repackager), Stryker (OEM) Lavage, jet
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered GIA Auto Suture Loading Units

    EXP Pharmaceutical Services Corp is recalling GIA Auto Suture Loading Units because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Laparoscopic Insufflation Needles

    EXP Pharmaceutical Services Corp is recalling two units of laparoscopic insufflation needles due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Transcatheter Septal Occluders

    EXP Pharmaceutical Services Corp is recalling 12mm vascular transcatheter septal occluders because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Sterile Laparoscope Pouches

    EXP Pharmaceutical Services Corp is recalling seven sterile laparoscope pouches because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls ETS FLEX 45 Endoscopic Articulating Linear Cutters

    EXP Pharmaceutical Services Corp is recalling ETS FLEX 45 endoscopic cutters because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) Implantable Staple.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Sterile Nonabsorbable Sutures and Sternotomy Wires

    EXP Pharmaceutical Services Corp is recalling 19 units of sterile nonabsorbable sutures and sternotomy wires due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Endo Catch Medical Devices

    EXP Pharmaceutical Services Corp is recalling two units of Endo Catch 10mm devices because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Mayfield Disposable Skull Pins

    EXP Pharmaceutical Services Corp is recalling Mayfield Disposable Skull Pins because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A1072; EXP (repackager), Integra (OEM) Holder, head, neurosurgical (skull clamp)
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls TAUT Intraducer Peritoneal Catheters

    EXP Pharmaceutical Services Corp is recalling TAUT Intraducer Peritoneal Catheters because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.6cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PI-63; EXP (repackager), Teleflex (OEM) Catheter, biliary, surgical
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls Chocolate Balloon Catheters Due to Registration Deficiencies

    EXP Pharmaceutical Services Corp is recalling one unit of a Chocolate Balloon Catheter because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Auto Suture Endo Universal Devices

    EXP Pharmaceutical Services Corp is recalling three Auto Suture Endo Universal devices because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173054; EXP (repackager), Tyco (OEM) Laparoscope, General & Plastic Surgery
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Angio-Seal Vascular Closure Devices

    EXP Pharmaceutical Services Corp is recalling three Angio-Seal VIP Platform vascular closure devices due to regulatory non-compliance regarding establishment registration and quality systems.

    Product
    Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular
    Category
    Distribution
    6 states