Z-0926-2017 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 11, 2017
- Initiation Date
- October 4, 2016
- Termination Date
- August 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 386,175 syringes
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
Reason for Recall
Potential contamination with B. cepacia.
Distribution Pattern
Worldwide Distribution - US (Nationwide), St. Thomas, US Virgin Islands, and Internationally to Canada.
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)