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Recall Observatory FDA recall evidence

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

November 21, 2014

Class II

Product summary

Firm
Becton Dickinson & Co.
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

    reason.microbial_contamination · v1.0.0

    Excessive oxidation may affect the viability of anaerobic microorganisms