Device product
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.
Z-1746-2015
Product summary
- Event
- Event 69954
- Status
- Terminated
- Classification
- Class II
- Quantity
- 145,860 tubes
- Official record key
device-enforcement:Z-1746-2015
Official wording
Reason: The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Microbial contamination
Excessive oxidation may affect the viability of anaerobic microorganisms