Recall Z-1898-2012 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
SALTER LABS
Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
| Date | Jun 27, 2012 (initiated May 30, 2012) |
| Status | Terminated |
| Reason | A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock connector actually contained product with a female luer lock connector. |
| Root cause | Packaging |
| Action | The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record via fax to: 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, plea |
| Quantity | 242 cases |
| Distribution | Nationwide distribution: USA including states of: FL, IN, KS, PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K892406 | MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA Salter Labs, Jul 24, 1989 |