FDA Medical Device Recalls (openFDA)
Nurse Assist, Inc: Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
- Recall number
- Z-0926-2017
- Recalling firm
- Nurse Assist, Inc
- Product
- Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP Product usage: Saline flush
- Status
- Terminated
- Initiated
- 2016-10-04
- Posted
- 2017-01-03
- Terminated
- 2017-08-16
- Reason
- Potential contamination with B. cepacia.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 386,175 syringes
- Distribution
- Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
- Lot, serial or model codes
- Item Number 1203: 1511075, 1604273; Item Number 1205: 1511001, 1602028, 1603060; Item Number 1210: 1509282, 1511328, 1511329, 1512048, 1512053, 1512072, 1601355, 1602048, 1602137, 1602178, 1603029, 1605387, 1606076; Item Number 1210-BP: 1604431,1604432, 1604433, 1606254, 1607018, 1607195, 1607418 (All lots within expiry)
- 510(k) numbers
- ["K150143"]
- PMA numbers
- not on file
- Product code
- NGT
- Firm FEI
- 3002695476
- Firm city
- Haltom City
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28