Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multipl
FDA device recall Z-2226-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Gyrus ACMI Corporation
- Reason for recall
- Particulate matter in the catheter
- Action taken
- Gyrus initiated a recall by letter dated 6/ 25 /08. An updated letter issued July 9, 2008 which supersedes the previous letter. The July 9th letter updates the lot numbers affected in the recall. A reply form request was sent to consignees informing them of the problem and asking them to obtain a RMA and return the product. They are also requested to FAX back a reply form so that the response can be tracked. For assistance, please contact Gyrus ACMI at 1-888-524-7266.
- Root cause
- Process control
- Status
- Terminated
- Product code
- EYB
- Quantity affected
- 6820 units
- Distribution
- Nationwide Foreign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey
- Date initiated
- 2008-06-25
- Date posted
- 2008-09-16
- Date terminated
- 2012-05-07
- Location
- Southborough, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL LUMEN CATHETER (K043581) | Acmi Corporation | 2005-03-03 |