Z-1746-2015Class II

BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and...

Name: Z-1746-2015 BBL Port A Cul tubes, catalog number 221606. Patient sample collection tubes. BBL Port A Cul tubes, jars and...
Creator: Becton Dickinson & Co.
Published: 2014-11-21
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-11-21 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of 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... on 2014-11-21. FDA classified it as Class II and gives the reason as "The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1746-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-21
Posted: 2015-06-10
Terminated: 2016-01-07
Recalling firm: Becton Dickinson & Co
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.
Product code: N/A
Reason for recall: The products may exhibit indications of excessive oxidation. Excessive oxidation may affect the viability of anaerobic microorganisms.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 145,860 tubes
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1746-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1746-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10
Z-1747-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)