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.

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 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 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 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
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 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 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 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 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 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 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 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 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 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 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 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
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 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 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 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
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 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 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 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 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 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