BD Vacutainer SST recallZ-2055-2018 · Becton Dickinson & Company · initiated Feb 13, 2018

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube

FDA root cause category: Nonconforming Material/Component

What the company is doing

On March 15, 2018 BD Life Sciences sent Urgent Medical Device Recall Notifications to affected customers. Customers were instructed to : 1. Immediately review your inventory for the subject lots and quarantine the product subject to the recall. 2. Share this recall notification with all users of the product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Return all affected products using the enclosed packaging instructions and include the completed Recall Response Form with the product. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: Medwatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088); Mail: MedWatch, HF-2, FDA 5600 Fisher's Lane, Rockville, MD 20853-9787. Customer who require further assistance should contact BD Preanalytical Systems at (877)870-4486, Mon-Fri 8:00am-5:00pm

Recall details

Recall number: Z-2055-2018
Status: Terminated
Initiated by the company: Feb 13, 2018
Posted by the FDA: Jun 1, 2018
Recalling firm: Becton Dickinson & Company
Quantity: 9,568,900 total products
Product code: JKA
FDA submissions: K023075
Distribution: US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan

Product description

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983

Code information (models, lots, serial numbers)

1) UDI DI (01)50382903679831 PI (17)180531(10)7135828(30)1000 Lot/Serial # 7315828 Exp Date 5/31/2018 2) UDI DI (01)50382903679831 PI (17)180531(10)7146901(30)1000 Lot/Serial # 7125692 Exp Date 4/30/2018

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

BD Vacutainer® SST™ 367983
Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
2 recalls1,075 reports

Product lines

BD Vacutainer SSTBecton, Dickinson And Company · 10 models · 4,985 reports · 3 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 79709).

Z-2056-2018 · Terminated
BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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