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Recall Observatory FDA recall evidence

Device 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

Z-0926-2017

October 04, 2016

Class I

Product summary

Firm
Nurse Assist, Inc
Event
Event 75348
Status
Terminated
Classification
Class I
Quantity
386,175 syringes
Official record key
device-enforcement:Z-0926-2017

Official wording

Reason: Potential contamination with B. cepacia.

Code information: 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)

Distribution pattern: Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential contamination with B. cepacia.