Medline medical device kits recalled for regulatory compliance rescission
Medline Industries has recalled six medical device kits (arthrogram trays, angiography packs, and neuro packs) because their 510(k) regulatory clearances have been rescinded by the FDA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving medical devices (control syringes, guidewires, and high-pressure tubing) used in interventional and surgical procedures. Rescission of 510(k) clearance for components in sterile kits used in critical procedures meets the threshold for Severe per the rubric criterion for Class II recalls affecting medical device safety.
Plain-English summary
Medline Industries, LP is recalling six models of sterile medical device kits distributed nationwide: Arthrogram Tray (DYNJ07425), TOL Neuro Angio Pack (DYNJ38610I), Angiography Pack (DYNJ45234A), C.I.C.N. Angio Pack (DYNJ53064B), DR. Alleyne Neuro Pack (DYNJ63779A), and Neuro CTM IR Pack (DYNJ87817). A total of 9,645 units are affected across multiple lot numbers.
The recall was initiated because the 510(k) regulatory clearances for control syringes, guidewires, and/or high-pressure tubing contained within these kits have been rescinded by the FDA. This means these components no longer have valid marketing authorization.
Healthcare facilities and providers who have received these kits should discontinue use and contact Medline Industries for further instructions regarding replacement or return of the affected units.
The recalled product
- Product
- Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: DYNJ38610I 3) ANGIOGRAPHY PACK, Model Number: DYNJ45234A 4) C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B 5) DR. ALLEYNE NEURO PACK, Model Number: DYNJ63779A 6) NEURO CTM IR P
- Manufacturer
- Medline Industries, LP
- Hazard
- regulatory-clearance-rescission
- unauthorized-marketing
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 (20)
- 1) DYNJ07425
- UDI-DI: 10080196866465(each)
- 40080196866466(case)
- Lot Number: 23DBP927
- 2) DYNJ07425
- Lot Number: 23EBS362
- 3) DYNJ38610I
- UDI-DI: 10198459323102(each)
- 40198459323103(case)
- Lot Number: 25DBM593
- 4) DYNJ38610I
- Lot Number: 25GBO740
- 5) DYNJ45234A
- UDI-DI: 10193489782554(each)
- 40193489782555(case)
- Lot Number: 23LBU617
- 6) DYNJ45234A
- Lot Number: 23HBK865
- 7) DYNJ53064B
- UDI-DI: 10193489789164(each)
Distribution
Distributed nationwide across the United States.