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Medline Convenience kits labeled as recallZ-2991-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Apr 8, 2024

Class II Open, Classified All recalls posted in September 2024

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 MEDLINE INDUSTRIES, LP - Northfield 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 contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

Recall details

Recall number
Z-2991-2024
Recall class
Class II
Status
Open, Classified
Initiated by the company
Apr 8, 2024
Posted by the FDA
Sep 6, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product code
LDF
FDA submissions
K803086
Distribution
Worldwide distribution.

Product description

Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

DYNJ41223, Lot Number 21HBU861 ; DYNJ41223, Lot Number 21KBA848 ; DYNJ41223, Lot Number 21KBA910 ; DYNJ41223, Lot Number 22ABA546 ; DYNJ41223, Lot Number 22MBA262 ; DYNJ41223, Lot Number 19BBC903 ; DYNJ41223, Lot Number 19CBO901 ; DYNJ41223, Lot Number 19DBW422 ; DYNJ41223, Lot Number 22HBY065 ; DYNJ41223, Lot Number 19HBD957 ; DYNJ41223, Lot Number 19HBJ856 ; DYNJ41223, Lot Number 19IBT476 ; DYNJ41223, Lot Number 22KBU048 ; DYNJ41223, Lot Number 19VBD385 ; DYNJ41223, Lot Number 19LBF954 ; DYNJ41223, Lot Number 23EBC280 ; DYNJ41223, Lot Number 23FBA251 ; DYNJ41223, Lot Number 20BBP883 ; DYNJ41223, Lot Number 20CBI263 ; DYNJ41223, Lot Number 23JBC138 ; DYNJ41223, Lot Number 23KBO541 ; DYNJ41223, Lot Number 20IBJ759 ; DYNJ41223, Lot Number 20JBE058 ; DYNJ41223, Lot Number 20XBF374

Other devices under the same FDA submission

5 devices cleared under K803086 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94583).

Sources and updates

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