Custom Healthcare Systems Recalls Cast Padding Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 30 units of cast padding kits because incorrect sealing specifications compromised product sterility.
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 3/5 (High).
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, and 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.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 30 units of CHS Custom Convenience Kit-SPECIALIST CAST PADDING (3" x 4 yds), Product Number D4-324SCP. The recall involves Lot 51418 with 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 in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Consumers and healthcare facilities should stop using the affected product and contact Custom Healthcare Systems, Inc. for further instructions or a return.
The recalled product
- Product
- CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Cast Padding
- Affected units
- 30
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: 51418 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.
See all 29 products in this recall →Related recalls
Same manufacturer · Custom Healthcare Systems, Inc.
See all →- HighCustom Healthcare Systems Recalls Inpatient Dialysis Kits Due to Latex
FDA (Devices) · 2020-02-05
- HighCustom Healthcare Systems Recalls Penrose Drain Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCustom Healthcare Systems Recalls Suture Removal Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCustom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCHS Custom Convenience Kits Recalled for Sterility Compromise
FDA (Devices) · 2018-10-31
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereCustomed Suction Catheter Kits Recalled for Compromised Sterility
FDA (Devices) · 2014-12-10
- SevereMedline Convenience Kits recalled for potential sterilization issues
FDA (Devices) · 2026-05-13
- SevereCustomed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Curation Kits Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Foley Catheter Kits Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10
- SevereCustomed Recalls Cystoscopy Packs Due to Potential Packaging Integrity Issues
FDA (Devices) · 2014-09-10