BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
This recall has been terminated (originally issued June 10, 2015).
- Recall Initiated
- November 21, 2014
- Posted
- June 10, 2015
- Terminated
- January 7, 2016
- Recall Number
- Z-1747-2015
- Quantity
- 92,710 units
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
Distribution
US Nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Lot / Code Info
Part/Cat No. Lot / Serial No.Date of Mfr Exp. Date 221607 4067181 3/19/2014 3/5/2015 221607 4083274 4/3/2014 3/20/2015 221607 4124706 5/9/2014 4/24/2015 221607 4127564 5/22/2014 5/1/2015 221607 4170891 7/8/2014 6/19/2015 221607 4006235 2/18/2014 12/26/2014 221607 4028420 2/19/2014 1/21/2015
Root Cause
Process control
Action Taken
BD Diagnostic Systems sent an Urgent Product Recall letter dated December 2014 to all affected customers. Recall notification was initiated on November 21, 2014, the notification was sent by fax and letters by UPS. Customer notification for the expansion of the recall was initiated on December 18, 2014, the notification was sent by fax and letters by UPS. For questions regarding this recall call 800-638-8663.