Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70
FDA device recall Z-2896-2016 · posted 2016-09-27 · Terminated
Recall details
- Recalling firm
- Zyno Medical LLC
- Reason for recall
- Administration Set potential filter leaking
- Action taken
- Zyno issued Recall letter dated July 26th, 2016 to affected customers. Customers who received affected products were contacted between 7/29/2016 and 8/1/2016. Customers were asked to return unused product for replacement. For questions contact Customer Service Representative, at 508-907-7796, or laryloring@zynomed.com. Expanded Recall: Two recall letters issued on 11/3/2016 to address the newly identified lots. One letter for customers who received the initial recall letter and the other letter for newly affected customers who did not receive the initial recall letter.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 47989 sets
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-07-29
- Date posted
- 2016-09-27
- Date terminated
- 2017-07-11
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZYNO MEDICAL ADMINISTRATION SET (K132841) | Zyno Medical, LLC | 2014-01-23 |