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BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) recallZ-0588-2021 · Becton Dickinson & Company · initiated Nov 18, 2020

Terminated

Is my device affected?

  1. 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.
  2. 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.
  3. 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

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-0588-2021
Status
Terminated
Initiated by the company
Nov 18, 2020
Recalling firm
Becton Dickinson & Company
Quantity
1,430,000
Product code
FMI
FDA submissions
K021475
Distribution
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.

Product description

BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.

Code information (models, lots, serial numbers)

Catalog Ref No.: 305106 Lot No:. 9128897 Expiration Date: 2024-06-30 UDI: 30382903051060 Product Package Size: 100 units per carton

Devices named in this recall

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

Other devices under the same FDA submission

45 devices cleared under K021475 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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