FDA Recalls Sterile Surgical Packs Due to Unregistered Facility
American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score per the rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
American Contract Systems is recalling 2,868 sterile custom packs intended for use in surgical procedures. The recall was initiated because 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 FBCS38I. The recall includes 4 kits from Lot # 692191 with an expiration date of 11/04/2020, and 40 kits from Lot # 648191 with an expiration date of 12/18/2020. These products were distributed nationwide in the United States, including in the state of Pennsylvania.
The FDA has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected sterile custom packs and contact American Contract Systems for further instructions.
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 (4)
- ACS Tray Numbers: FBCS38I
- Lot # 692191
- Exp. Date 11/04/2020 (4 kits) and Lot # 648191
- Exp. Date 12/18/2020 (40 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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