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Terminated

Barrier Hip Sheet with Side Pockets

FDA Recall Z-1137-03 · Posted 2003-08-14

Recalling FirmMolnlycke Health Care Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2003-07-14
Date Terminated2003-11-10
Product Quantity2714 units

Reason for Recall

pouch may tear which could result in contamination of sterile field

Firm Action

The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K780282BARRIER HIP PACK W/ FABRIC 450Surgikos, Inc. · 1978-02-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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