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

FDA device recall Z-2055-2018 · posted 2018-06-01 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

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

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JKA

Quantity affected

9,568,900 total products

Distribution

US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan

Date initiated

2018-02-13

Date posted

2018-06-01

Date terminated

2020-03-09

Location

Franklin Lakes, NJ

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