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BD SafetyGlideTM 3ml 25G x 1 recallZ-2889-2020 · Becton Dickinson & Company · initiated Jul 28, 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

Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.

FDA root cause category: Equipment maintenance

What the company is doing

BD Sent a customer letter dated 28 July 2020. this letter requests customers to review their inventory for effected lots and Destroy all product subject to the recall. The letter requests customers to return the included response form and notify BD of any adverse events associated to this product.

Recall details

Recall number
Z-2889-2020
Status
Terminated
Initiated by the company
Jul 28, 2020
Recalling firm
Becton Dickinson & Company
Quantity
125,200 units
Product code
FMI
FDA submissions
K951254
Distribution
US and Canada

Product description

BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack

Code information (models, lots, serial numbers)

Catalog #: 305924 Lot #: 8289599 UDI #: 30382903059240

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

19 devices cleared under K951254 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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