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Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420 recallZ-1554-2021 · Medical Action Industries, Inc. 306 · initiated Apr 9, 2021

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 Medical Action Industries, Inc. 306 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

Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

FDA root cause category: Package design/selection

What the company is doing

A written notification letter titled, "URGENT: RECALL NOTIFICATION" was sent to all consignees on 04/09/2021 via email. The letter sent to the distributors instructs the consignees to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignees are instructed to discard any inventory they may have on hand in accordance with the distributor's facility s standard procedures. If any of the affected products identified above were further distributed, the distributor is to ensure all end-users are appropriately notified of this product recall and maintain records of effectiveness. An example of an end-user letter that the distributor can use to notify their customers is attached. The distributor is asked to please report number of responses received and quantities destroyed to [email protected]. The consignee is asked to complete the Recall Response Form and return it as soon as possible even if they do not have product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Material Authorization form when the recalled product is destroyed and return to [email protected] to receive credit. The letter also mentions that any adverse events associated with the use of the affected kits should be reported to [email protected]. The letter that was sent to the end users instructs the consignee to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignee is to discard any inventory they may have on hand in accordance with their facility' s standard procedures. The consignee is to complete the Recall Response Form and return it as soon as possible even if the consignee has no current product inventory. If the facility has identified recalled product in their inventory, they are asked to please complete the attached Destruction of Ma

Recall details

Recall number
Z-1554-2021
Status
Terminated
Initiated by the company
Apr 9, 2021
Posted by the FDA
May 12, 2021
Recalling firm
Medical Action Industries, Inc. 306
Quantity
30 cases (20 kits per case)
Product code
PEZ
Distribution
Distributed US nationwide to OH, OR, FL and CA.

Product description

Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420

Code information (models, lots, serial numbers)

Kit Number: 79420; UDI (GTIN): 20809160247775; Lot Number: 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022)

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 87722).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page