Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203
FDA device recall Z-0926-2017 · posted 2017-01-03 · Terminated
Recall details
- Recalling firm
- Nurse Assist, Inc
- Reason for recall
- Potential contamination with B. cepacia.
- Action taken
- Nurse Assist, Inc. sent an Urgent Medical Device Recall letter dated October 4, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use, a Returned Goods Authorization would be provided for return of the affected product. If product was further distributed consignees were instructed to make every effort to retrieve any of the unused product. For questions consignees should call 800-649-6800 or email productremovalinfo@nurseassist.com. For questions regarding this recall call 817-231-1300.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 386,175 syringes
- Distribution
- Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
- Date initiated
- 2016-10-04
- Date posted
- 2017-01-03
- Date terminated
- 2017-08-16
- Location
- Haltom City, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Normal Saline Flush (K150143) | Nurse Assist, Inc. | 2015-08-31 |