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.
Check against the official notice below — it lists the full affected range.
American Contract Systems Inc. is recalling medical procedure kits and trays containing Ritmed Neurological Sponges Non-Sterile (Models 55992C to 55998C) due to potential unexpected variability in endotoxin levels on the sponges. The recall affects 160 kits distributed to Minnesota, Missouri, and Iowa. The affected products include Anterior Cervical Pack and Spine Pack kits with specific lot numbers and model numbers, with the UDI/DI identifiers and lot numbers listed in the recall record.
The source document does not specify what an affected consumer should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US distribution to states of: MN, MO, IA Quantity: 160 kits Lot/code info: Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8606211; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8687611; Model/Item Number MHAC65AH, UDI/DI 191072211910, Lot Number 42-8847511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8423411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8470411; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8527611; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8601311; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8731511; Model/Item Number MHSP99AF, UDI/DI 191072214782, Lot Number 42-8795311.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.