Recall Z-2388-2021— Aspen Surgical Products, Inc.
Class II · Terminated
Class II FDA medical device recall by Aspen Surgical Products, Inc., initiated 2021-07-23, terminated 2022-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300. Reason: Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection..
- Recalling firm
- Aspen Surgical Products, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-23
- Terminated
- 2022-07-26
- Firm location
- Caledonia, MI, United States
Product description
Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
Reason for recall
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.