Custom Healthcare Systems Recalls 50 Curved Pean Forceps Kits
Custom Healthcare Systems is recalling 50 units of curved pean forceps kits because incorrect sealing specifications compromised product sterility.
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 compromised sterility of a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 50 units of CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") (Product Number: D36-16669). The affected products are identified by Lot number 52418 and have an expiration date of 5/1/2021.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the sterility of the product. The affected units were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Healthcare facilities should stop using the affected products immediately and contact Custom Healthcare Systems, Inc. for further instructions regarding the return or disposal of the recalled items.
The recalled product
- Product
- CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 50
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 (1)
- Lot number: 52418 Exp. Date: 5/1/2021
Distribution
Part of a larger recall action
This product is one of 29 recalled by Custom Healthcare Systems, Inc. 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.
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