Nasal Cannula (Adult) Salter Style with modified nasal prongs, 7" (2.1M) Q supply tube and CO2 sample tube with male lue
FDA device recall Z-2237-2011 · posted 2011-05-20 · Terminated
Recall details
- Recalling firm
- Salter Laboratories, Division of Regulatory Affairs
- Reason for recall
- Complaint received that the product in the box was different from labeled product.
- Action taken
- The firm, Salter Labs, sent an "URGENT PRODUCT RECALL" subtitled Adult Divided Cannula Product Code 4707 Lot 012411, letter dated April 19, 2011 via certified mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory; return any of the lot in their possession to Salter; contact Salter Customer Service at 1-800-235-4203 to arrange for the return of the product, and complete and return the Customer Reply Form 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
- Labeling mix-ups
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 22,150 pieces
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-04-19
- Date posted
- 2011-05-20
- Date terminated
- 2011-08-23
- Location
- Arvin, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA (K892406) | Salter Labs | 1989-07-24 |