Sengstaken Tube and Sengstaken-Blakemore Tube. Teleflex product codes 204800, 204802, and 204803, a gastrointestinal tub
FDA device recall Z-1506-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Sterility of the product cannot be guaranteed.
- Action taken
- Letters were issued on 3/4/2014 to consignees asking them to immediately discontinue use and quarantine any products with the recalled catalog numbers. Distributors were also asked to conduct a sub-recall. The recall letters included a Recall Acknowledgment Form which was to be faxed back to Teleflex.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 117,801 ea.
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, AK, AR, CA, CO, FL, GA, ID, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PA, SC, TN, TX, UT, VT, VA, WA, WV,
- Date initiated
- 2014-03-04
- Date posted
- 2014-04-24
- Date terminated
- 2016-01-28
- Location
- Durham, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUSCH BLAKEMORE 3 LUMEN, STERILE (K981203) | Rusch Intl. | 1998-06-05 |