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Terminated

RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

FDA Recall Z-2154-2014 · Posted 2014-08-06

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeFCM
Date Initiated2014-07-10
Date Terminated2015-11-25
Product Quantity720

Reason for Recall

Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

Firm Action

Consignees were notified via letter on/about 07/10/2014.

Root Cause

Process control

Distribution Pattern

Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K901185FOLEY CATHETER INSERTION TRAY (10CC)Orion Life Systems, Inc. · 1990-07-20

Official Source

View FDA Recall →

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

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