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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-2154-2014
Recalling firm
Teleflex Medical
Product
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Status
Terminated
Initiated
2014-07-10
Posted
2014-08-06
Terminated
2015-11-25
Reason
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.
Root cause
Process control
Action
Consignees were notified via letter on/about 07/10/2014.
Quantity
720
Distribution
Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
Lot, serial or model codes
Product Code: 76730, Lot number: 307505.
510(k) numbers
["K901185"]
PMA numbers
not on file
Product code
FCM
Firm FEI
3005747797
Firm city
Durham
Firm state
NC
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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