Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
FDA Recall Z-0936-2013 · Posted 2013-03-11
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Recalling FirmBacterin International, Inc.
Recall StatusTerminated
Product CodeOEI
Date Initiated2013-01-28
Date Terminated2013-07-08
Product Quantity15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Reason for Recall
A portion of a silicone wound drain was found to be cracked.
Firm Action
Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.
Root Cause
Nonconforming Material/Component
Distribution Pattern
13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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