Medline Surgical Kits Recalled Due to Rescinded Regulatory Clearances
Medline Industries is recalling 41 different surgical kit models nationwide because regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. Affected facilities should stop use and contact Medline.
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 (surgical kits with cleared components now lacking valid regulatory clearance). The kits are used in critical medical procedures and the loss of regulatory clearance for key internal components (control syringes, guidewires, high-pressure tubing) represents a significant device defect affecting multiple patient-critical applications, meeting the Severe threshold.
Plain-English summary
Medline Industries, LP is recalling 41 surgical kit models distributed nationwide. The kits include newborn admission kits, cardiac catheterization packs, neuro packs, pacemaker packs, vascular packs, and various other surgical trays. A total of 38,014 units have been distributed.
The recall has been initiated because the 510(k) regulatory clearances for certain control syringes, guidewires, and/or high-pressure tubing components within these kits have been rescinded. This means these components no longer have valid FDA clearance for use.
Healthcare facilities that have received these kits should stop using them immediately. Facilities should identify affected inventory using the provided model numbers and lot numbers, and contact Medline Industries for instructions on return or replacement. The FDA is asking Medline to notify customers of this recall.
The recalled product
- Product
- Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA3188; 3) VA ORLANDO SHOULDER PACK, Model Number: DYNJG001027B; 4) TUMESCENT SYRINGE KIT, Model Number: DYNJTUMSYR; 5) OMC PTCA PACK, Model Number: DYNJT3719; 6) PORT PACK,
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- regulatory-clearance-rescinded
- control-syringe
- guidewire
- high-pressure-tubing
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) DYKB1038
- UDI-DI: 10193489502428(each)
- 40193489502429(case)
- Lot Number: 22GBJ869
- 2) DYNDA3188
- UDI-DI: 10198459303579(each)
- 40198459303570(case)
- Lot Number: 25DBF256
- 3) DYNJG001027B
- UDI-DI: 10198459065453(each)
- 40198459065454(case)
- Lot Number: 25ELA998
- 4) DYNJG001027B
- Lot Number: 25ELA723
- 5) DYNJTUMSYR
- UDI-DI: 10884389882054(each)
- 40884389882055(case)
- Lot Number: 21BBH579
- 6) DYNJTUMSYR
- Lot Number: 21BBS213
Distribution
Distributed nationwide across the United States.