BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and vials contain a reduced transport medium and are intended to maintain the viability of anaerobic, facultative and aerobic microorganisms during transport from the patient to the laboratory. Sterile packages are for collection of specimens in clean areas; e.g., surgical suites.
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-1746-2015
- Quantity
- 145,860 tubes
- 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 221606 4042455 2/25/2014 2/5/2015 221606 4067180 3/18/2014 3/5/2015 221606 4087204 4/10/2014 3/25/2015 221606 4124702 5/8/2014 4/24/2015 221606 4161968 7/7/2014 6/12/2015 221606 4181959 7/14/2014 7/3/2015 221606 4032407 2/14/2014 1/29/2015 221606 4042069 2/17/2014 2/4/2015
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.