FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves the use of unregistered facility products in surgical procedures, representing a risk of harm where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for sterile custom packs intended for use in surgical procedures. The recalling firm, American Contract Systems, is recalling a total of 2,868 kits. The specific reason for the recall is that the surgical gowns included in these packs were manufactured in a facility that is not registered by the FDA.
The affected products are identified by ACS Tray Number AVLC19G, Lot # 642191, and an expiration date of 12/24/2020. This specific lot consists of 64 kits. The products were distributed nationwide in the United States, including in the state of Pennsylvania.
Healthcare facilities and consumers who have these specific sterile custom packs should stop using them immediately and contact American Contract Systems for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Manufacturer
- American Contract Systems
- Affected units
- 2,868
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 (3)
- ACS Tray Numbers: AVLC19G
- Lot # 642191
- Exp. Date 12/24/2020 (64 kits)
Distribution
Part of a larger recall action
This product is one of 14 recalled by American Contract Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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