Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60
FDA Recall Z-1492-04 · Posted 2004-09-29
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Recalling FirmDeroyal Surgical -Rose Hill
Recall StatusTerminated
Product CodeKKX
Date Initiated2004-09-09
Date Terminated2005-05-16
Product Quantity19 cases
Reason for Recall
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
Firm Action
The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
Root Cause
Other
Distribution Pattern
Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
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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