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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to regulatory compliance (unregistered facility) rather than a specific high-risk pathogen or structural defect causing immediate harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for sterile custom packs intended for use in surgical procedures. The recalling firm is American Contract Systems. The recall involves a total of 2,868 kits.
The reason for the recall is that the surgical gowns contained in these packs were manufactured in a facility that is not registered by the FDA. The specific product code identified is ACS Tray Number FBPL271, Lot # 656191, with an expiration date of 12/10/2020. This specific lot consists of 32 kits.
The products were distributed nationwide in the United States, including in the state of Pennsylvania. Consumers and healthcare facilities should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Manufacturer
- American Contract Systems
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: FBPL271
- Lot # 656191
- Exp. Date 12/10/2020 (32 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
Same manufacturer · American Contract Systems
See all →- ModerateFDA Recalls Sterile Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
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FDA (Devices) · 2020-06-10
- HighFDA Recalls Sterile Custom Surgical Packs from Unregistered Facility
FDA (Devices) · 2020-06-10
- ModerateFDA Recalls Surgical Gowns from Unregistered Facility
FDA (Devices) · 2020-06-10
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