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U.S. Department of Health and Human Services

Class 2 Device Recall Specimen retriever bag

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  Class 2 Device Recall Specimen retriever bag see related information
Date Initiated by Firm February 11, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on December 30, 2015
Recall Number Z-2229-2015
Recall Event ID 71608
Product Classification Staple, implantable - Product Code GDW
Product Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number ATS45;
EXP (repackager), Ethicon (OEM)

Implantable Staple.
Code Information OEM Catalog number ATS45.
Recalling Firm/
EXP Pharmaceutical Services Corp
48021Warm Springs Boulevard
Fremont CA 94539
For Additional Information Contact Frederick R. Jorgenson, Esq.
Manufacturer 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.
FDA Determined
Cause 2
Action EXP first notified their customers to quarantine EXP devices February 11-17, 2015. Customers were contacted through telephone, e-mail, and written communications. Customers were instructed to recover and quarantine all EXP products from their inventories. EXP believes that they have contacted all customers to whom products were shipped between April 26, 2014, and December 9, 2014. A second letter is scheduled to be sent in July 2015 (date unknown at this time). This letter will advise users of the recall of due to lack of registration with the FDA.
Quantity in Commerce 3
Distribution Distributed in DC and the states of CO, CA, FL, TX, and AR.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.