Medline Convenience Kits: 1) Burn Pack, Model Number: Dynj15668r; 2) Burn Pack-lf, Model Number: Dynj42829b; 3) Burn Care Pack-lf, Model Number: Dynjt3437

Recall Summary Medline is recalling three burn care kit models (DYNJ15668R, DYNJ42829B, and DYNJT3437) because equipment used to sterilize and package them had calibration problems that may have affected the sterility of the products. The kits were processed through sterilization, but the calibration issues create a potential risk that they may not be adequately sterile.

Product

Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437

Reason

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Classification

Class I

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/99890a81-ac39-4cf8-bc22-739f529d164e