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 recalls 12mm Dilating Tip Trocars due to registration violations

    EXP Pharmaceutical Services Corp is recalling 12mm Dilating Tip Trocars because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D12LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
    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 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 Device Exchange Surgical Gowns

    EXP Pharmaceutical Services Corp is recalling 10 units of Medical Device Exchange Surgical Gowns because the company failed to register as a medical device establishment or establish a quality system.

    Product
    Medical Device Exchange Surgical Gown - Flyte Hood Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 408-800 EXP (repackager) Stryker (OEM) Person protection during surgery.
    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
  • 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 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 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 Unregistered Suction Coagulator Devices

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

    Product
    Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number E2505-10FR; EXP (repackager), Valleylab (OEM) Electrosurgical, cutting & coagulation & accessories
    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 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 Recalls Fiberwire Suture Scissors Due to Registration Violations

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

    Product
    Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number AR-11796; EXP (repackager), Arrow (OEM) Electrosurgical, cutting & coagulation & accessories.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls PhysioMesh Surgical Mesh Due to Registration Violations

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

    Product
    Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1515Q; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
    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 12 unregistered sterile dilating tip trocars

    EXP Pharmaceutical Services Corp is recalling 12 sterile dilating tip trocars because the company failed to register as a medical device establishment or maintain a quality system.

    Product
    Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 11mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number D11LT; EXP (repackager), Ethicon (OEM) Laparoscope, General & Plastic Surgery
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls PhysioMesh Surgical Mesh Due to Regulatory Non-Compliance

    EXP Pharmaceutical Services Corp is recalling two units of PhysioMesh surgical mesh because the company failed to register as a medical device establishment or maintain its own quality system.

    Product
    Medical Device Exchange PhysioMesh Flexible Composite Mesh 10cm x 15cm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number PHY1015V; EXP (repackager), Ethicon (OEM) Mesh, surgical, polymeric
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2015-08-05

    EXP Recalls Unregistered Orthopedic Saw Blades Due to Regulatory Non-Compliance

    EXP Pharmaceutical Services Corp is recalling two sterile orthopedic saw blades because the company failed to register as a medical device establishment or establish its own quality system.

    Product
    Medical Device Exchange X-SAW BLADE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 5059-531; EXP (repackager), Linvatic Corp (OEM) Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
    Category
    Distribution
    6 states