United StatesAmerican Contract Systems medical procedure kits and trays—including CRANI PACK (208400, Model UDCP57AI), SPINE PACK (Model HSLM53AC), CRANIAL PACK (205992, Model MHCP75AH), IMRI CRANI PACK (213871, Model ANCI17AO) and multiple other named packs and model numbers—are being recalled. The recall was initiated because Medicom is recalling specific lots of Ritmed Neurological Sponges Non‑Sterile (Models 55992C–55998C) due to potential for unexpected variability of endotoxin levels on the products.
What's being recalled
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
Recalling firm: American Contract Systems Inc, Tiffin, OH, United States.
How to identify it
Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8388111; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8474311; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8521711; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8547611; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8672411; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8775211; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8810511; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8447111; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8548311; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8630311; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8785011; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8742911; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8455911; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8498111; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8538111; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8601211; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8764511; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8823811; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8384311; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8525011; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8611711; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8705911; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8798411; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8831911; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8854511; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8497911; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8537311; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot…
The hazard
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to states of: MN, MO, IA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)