Recalls / —
—#128594
Product
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
- FDA product code
- FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K901185
- Affected lot / code info
- Product Code: 76730, Lot number: 307505.
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
Consignees were notified via letter on/about 07/10/2014.
Recalling firm
- Firm
- Teleflex Medical
- Address
- 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000
Distribution
- Distribution pattern
- Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.
Timeline
- Recall initiated
- 2014-07-10
- Posted by FDA
- 2014-08-06
- Terminated
- 2015-11-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #128594. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.