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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential contamination with B. cepacia."
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
- Hazard
- 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
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