Medline 10mL Polycarbonate Syringes in Convenience Kits recalled
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance. The kits were distributed nationwide in the US and to Canada, Panama, and Barbados.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class II recall. Per the rubric, FDA Class II recalls are typically scored at 3 or higher; however, because this involves an unapproved design change to medical device syringes used in angiography and catheterization procedures (high-risk clinical settings), and no reported illnesses or injuries are stated, the score is 4 (Severe) based on the high-risk nature of the affected medical devices and procedures.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits that contain select SKUs of 10mL polycarbonate colored syringes. The kits include multiple product configurations such as Judkins Packs, Angio Packs, Angio Trays, Angiography Packs, Cath Lab Angio Packs, and related angiography setup kits. A total of 270,311 units have been recalled.
The reason for the recall is that unapproved design changes were made to the products outside of the 510(k) clearance scope. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including US nationwide distribution as well as distribution to Canada, Panama, and Barbados. Specific lot numbers are identified in the recall notice and span multiple product SKUs.
Customers in possession of affected lots should stop using these products and contact Medline Industries for instructions on return or replacement.
The recalled product
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS PACK DYNJ51126 ANGIO PACK DYNJ32555C, DYNJ66631 ANGIO TRAY DYNJ46153B ANGIOGRAPHY PACK DYNJ26855F ANGIOGRAPHY PACK-M-LF DYNJ24530I ANGIOGRAPHY TRAY-LF…
- Manufacturer
- Medline Industries, LP
- Affected units
- 270,311
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- DYNJ66631 Lots 21IBH359 21VBC892 22BBW852 22DBJ281 22EBJ532 22GBA380
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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