Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For S
FDA device recall Z-1898-2012 · posted 2012-06-27 · Terminated
Recall details
- Recalling firm
- SALTER LABS
- Reason for recall
- 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.
- Action taken
- 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, please contact Salter Labs at 1-800-235-4203.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 242 cases
- Distribution
- Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
- Date initiated
- 2012-05-30
- Date posted
- 2012-06-27
- Date terminated
- 2012-07-27
- Location
- Arvin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA (K892406) | Salter Labs | 1989-07-24 |