The Recall Desk
HighFDA (Devices)·Z-0926-2017·Announced 2017-01-11

Nurse Assist Recalls Normal Saline Flush Syringes Due to B. cepacia Contamination

Nurse Assist, Inc. is recalling Normal Saline Flush syringes due to potential contamination with B. cepacia. The affected products were distributed in the US, US Virgin Islands, and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk pathogen (B. cepacia) in a medical device without reported illness, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Nurse Assist, Inc. is recalling Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringes in 3 ml, 5 ml, and 10 ml fills. The recall involves product codes 1203, 1205, 1210, and 1210-BP. The total quantity of affected syringes is 386,175 units.

The recall is being conducted due to potential contamination with B. cepacia. The affected products were distributed nationwide in the United States, in St. Thomas, US Virgin Islands, and internationally to Canada. Specific lot numbers are listed in the structured product information for each item number.

Consumers and healthcare facilities should stop using the affected syringes and contact Nurse Assist, Inc. for further instructions or a refund. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

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
Manufacturer
Nurse Assist, Inc
Affected units
386,175

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: