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Terminated

Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07

FDA Recall Z-1120-2019 · Posted None

Recall StatusTerminated
Product CodeFPA
Date Initiated2019-03-05
Date Terminated2020-07-15
Product Quantity21220 total cases of 20

Reason for Recall

The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Firm Action

On March 5, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that product was being recalled due to reports of kinked tubing which can lead to occlusion of the sets and reduction in the rate of infusion. Please Take the Following Actions: 1. Immediately review your inventory for the specific Catalogues (Ref) and lot numbers 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 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 and provide product replacement. If you require further assistance, please contact: Customer Advocacy Phone: 888-812-3266 Phone hours: 24 hours a day, 7 days a week Email: [email protected]

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed to accounts in AL, CA, DC, FL, LA, MD, NE, TN, VA, and WA.

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.

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