Recall StatusTerminated
Date Initiated2020-11-18
Date Terminated2024-02-15
Product Quantity1,430,000
Reason for Recall
BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
Firm Action
Customers are provided with the following actions to take in the firm's recall notification letter:
1. Immediately review your inventory for the specific Catalog (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 within or outside your facility network
to which you may have further distributed the affected 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 per FDA
requirements and subsequently process your product replacement.
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 via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA-1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
Replacements will be provided for all discarded inventory.
If you require further assistance, please contact:
BD Contact: Customer/Technical Support
US Contact Information: (844) 823-5433 MonFri 8:30am and 5:00pm (EST)
Areas of Support: For customers outside the US, contact your local BD representative or distributor
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA
and the countries of Canada, China, Singapore.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.