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

26–42 of 42

  • 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 Implantable Staple Loading Units

    EXP Pharmaceutical Services Corp is recalling three units of implantable staple loading units because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Suction Devices

    EXP Pharmaceutical Services Corp is recalling sterile suction devices because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange - Silicone Round Drain; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number SU130-1321; EXP (repackager), Jackson Pratt (OEM) Apparatus, suction, single patient use, portable, nonpowered
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls Unregistered Medical Device Exchange Round Diamond Bur

    EXP Pharmaceutical Services Corp is recalling Round Diamond Bur Extra Coarse devices because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-130; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Implantable Skin Staple Systems

    EXP Pharmaceutical Services Corp is recalling three units of implantable skin staple systems because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Pharmaceutical Services Recalls Unregistered Medical Device Repackaging Operations

    EXP Pharmaceutical Services Corp is recalling 12x40 Airway Stent Systems due to failure to register as a medical device establishment and lack of a quality system.

    Product
    Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-212; EXP (repackager), Aero (OEM) Prosthesis, tracheal, expandable
    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 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
  • 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 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 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
  • LowFDA (Devices)··2015-08-05

    EXP Recalls 6.0mm Round Fluted Bur Due to Registration Deficiencies

    EXP Pharmaceutical Services Corp is recalling 5 units of 6.0mm Round Fluted Bur Soft Touch because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange 6.0mm Round Fluted Bur Soft Touch; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-160; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP recalls Stryker Round Fluted Burs due to registration violations

    EXP Pharmaceutical Services Corp is recalling Stryker Round Fluted Burs because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5820-10-120; EXP (repackager), Stryker (OEM) Drills, burrs, trephines & accessories (simple, powered)
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls Unregistered Implantable Clips Due to Regulatory Non-Compliance

    EXP Pharmaceutical Services Corp is recalling 17 units of implantable clips because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
    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 Recalls Unregistered Surgical Routers for Crani-A Procedures

    EXP Pharmaceutical Services Corp is recalling four surgical routers because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number A-CRN-S; EXP (repackager), Anspach (OEM) Bur, surgical, general & plastic surgery
    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