Normal Saline Flush 0.9% USP Sodium Chloride Injection… recallZ-0926-2017 · Nurse Assist, Inc · initiated Oct 4, 2016
Class I Terminated All recalls posted in January 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nurse Assist, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential contamination with B. cepacia.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
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 [email protected]. For questions regarding this recall call 817-231-1300.
Recall details
- Recall number
- Z-0926-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Oct 4, 2016
- Posted by the FDA
- Jan 3, 2017
- Recalling firm
- Nurse Assist, Inc
- Quantity
- 386,175 syringes
- Product code
- NGT
- FDA submissions
- K150143
- Distribution
- Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
Product description
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
Code information (models, lots, serial numbers)
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)
Other devices under the same FDA submission
3 devices cleared under K150143 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Halyard SS010Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall2 reports
- Halyard SS005Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
- Halyard SS003Owens & Minor Distribution, Inc. · Saline, vascular access flush1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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