BD Microtainer Tubes with FE (Sodium Fluoride / Disodium… recallZ-0061-2020 · Becton Dickinson & Company · initiated May 13, 2019

Why it was recalled

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

FDA root cause category: Process control

What the company is doing

Becton Dickinson (BD) notified consignees affected by letter via UPS and email dated May 13,2019. Letter describes reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific catalog and lot numbers listed below, 2. Destroy all product subject to the recall following your institution's process for destruction, 3. Share this Urgent Medical Device Recall notification with all users of the product to ensure that they are also aware of this recall, and 4. Complete the attached Customer Response/Certificate of Destruction Forms 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. Distributors provide their customer list to BD. BD PAS will notify these customers via mail. BD Contact US Contact Information Customer/Technical Support 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT).

Recall details

Recall number

Z-0061-2020

Status

Terminated

Initiated by the company

May 13, 2019

Recalling firm

Becton Dickinson & Company

Product code

JKA

FDA submissions

K002456, K991702

Distribution

Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN

Product description

BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

Devices named in this recall

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

• BD Microtainer® Tubes w/ FE (Sodium Fluoride/Disodium EDTA) Glycolytic Inhibitor 365992

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  1 recall5 reports

Other devices under the same FDA submission

6 devices cleared under K002456, K991702 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• BD Microtainer® SST™ - Amber 365978

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  2 recalls17 reports
• BD Microtainer® PST™ Tubes with LH (Lithium Heparin) 365985

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  1 recall65 reports
• BD Microtainer® SST™ 365967

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  1 recall56 reports
• BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber 365987

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  1 recall26 reports
• BD Microtainer® Tubes with LH (Lithium Heparin) 365965

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  1 recall16 reports
• BD Microtainer® Z (No Additive Tubes) 365963

  Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection
  1 recall14 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 82851).

• Z-0054-2020 · Terminated
  BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
• Z-0055-2020 · Terminated
  BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
• Z-0056-2020 · Terminated
  BD Microtainer SST Part/Catalog No.365967
• Z-0057-2020 · Terminated
  BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
• Z-0058-2020 · Terminated
  BD Microtainer SST- Amber Part/Catalog Number: 365978
• Z-0059-2020 · Terminated
  BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
• Z-0060-2020 · Terminated
  BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987