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. The hazard involves the use of medical devices from an unregistered facility, which poses a risk of harm, but the source text does not report any specific illnesses, injuries, or fatalities, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 2,868 sterile custom packs intended for use in surgical procedures. The recalling firm is American Contract Systems. 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 the following codes: ACS Tray Number AGLH66F, Lot # 674191 (244 kits), and ACS Tray Number AGAD45I, Lot# 681191, Exp. Date 11/15/2020 (35 kits). The source text does not specify the expiration date for the first lot. These products were distributed nationwide in the United States, including in the state of Pennsylvania.
Healthcare facilities and consumers should stop using these specific sterile custom packs immediately. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Manufacturer
- American Contract Systems
- Category
- Medical Device — Surgical Packs
- 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 (5)
- ACS Tray Numbers: AGLH66F
- Lot # 674191
- Exp. Date [date] (244 kits) AGAD45I
- Lot# 681191
- Exp. Date 11/15/2020 (35 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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