Z-0252-2020Class II

BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

Name: Z-0252-2020 BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Creator: Becton Dickinson & Company
Published: 2019-03-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-03-07 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608 on 2019-03-07. FDA classified it as Class II and gives the reason as "BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage". 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-0252-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Posted: 2019-10-31
Terminated: 2022-02-11
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 7, 2019, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed of the missing bevel, which may ultimately cause leakage if the needle damages the sleeve. ***UPDATED 7/11/19*** In July 2019, the firm sent out an additional notice, informing customers that two additional lots of the product were found to also be affected by the recall. ***UPDATED 12/10/19*** ON 12/4/19, the firm sent out a second expansion letter, informing that customers that an additional lot of product (lot 9010765) was also found to be missing the bevel from the non-patient needle end of the product. ***END UPDATE*** Customers were asked to take the following actions: 1. Immediately review your inventory for the specific Catalogue (Ref) and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response 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. The firm stated it would provide replacement for all discarded inventory. ***PUBLIC CONTACT ADDED 7/11/19*** If you have any questions, you may reach BD Customer/Technical Support at 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT)
Quantity in commerce: 2,624,160 (2,169,703 US; 454,457 OUS)
Distribution: Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan.
Product codes and lots: Lot 8207894 ***UPDATED 7/11/19*** Lots 9025826 and 8354527 ***UPDATED 12/10/19*** Lot 9010765

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0252-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0252-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code FMI

K982541Class IIVacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608Becton Dickinson Vacutainer Systems / cleared 1998-10-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)