FDA Device recall Z-3137-2026
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N by Medline Industries, citing the kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3137-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-23 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
Reason
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction.
Identifiers
| code_info | UDI-DI: 10198459445941 (each), 40198459445942 (case); Lot Numbers: 25HLA462, 25HLA916, 25JLA847, 25LLA298, 26CLA372 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
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FDA Device · Class I · 2026-10-07 · Medline Industries - Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants: MDR510094 PENDANT F/ MDR107002E MDR520094 PENDANT F/…
FDA Device · Class I · 2026-10-07 · Medline Industries - Medline convenience kits containing Healthmark Instrument Channel Brushes
FDA Device · Class II · 2026-09-30 · Medline Industries - Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I
FDA Device · Class II · 2026-09-30 · Medline Industries - Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197
FDA Device · Class II · 2026-09-30 · Medline Industries
All Medline Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3137-2026%22
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