Home / Recalls / EXP Pharmaceutical Services Corp / Z-2228-2015

Z-2228-2015 Class II Terminated

Recalled by EXP Pharmaceutical Services Corp — Fremont, CA

FDA device recall Z-2228-2015 was initiated by EXP Pharmaceutical Services Corp on February 11, 2015 and is designated Class II. Reason for recall: 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 th… The recall status is terminated (terminated December 30, 2015). Affected quantity: 2.

Recall Details

Product Type
Devices
Report Date
August 5, 2015
Initiation Date
February 11, 2015
Termination Date
December 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Distributed in DC and the states of CO, CA, FL, TX, and AR.

Code Information

OEM Catalog number 2444.

Other recalls by EXP Pharmaceutical Services Corp

  • Z-2238-2015 Class II — Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/Mylar (February 11, 2015)
  • Z-2230-2015 Class II — Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Sterile, (February 11, 2015)
  • Z-2229-2015 Class II — Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45M (February 11, 2015)
  • Z-2233-2015 Class II — Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use (February 11, 2015)
  • Z-2222-2015 Class II — Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar, S (February 11, 2015)
  • Z-2212-2015 Class II — Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Ste (February 11, 2015)
  • Z-2243-2015 Class II — Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch, T (February 11, 2015)
  • Z-2227-2015 Class II — Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, (February 11, 2015)
  • Z-2215-2015 Class II — Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek/My (February 11, 2015)
  • Z-2235-2015 Class II — Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use O (February 11, 2015)

FDA data resources