Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
FDA Recall Z-1121-2019 · Posted None
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Recalling FirmBecton Dickinson & Company
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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