Hollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.
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: This is a FDA Class II medical device recall due to a packaging integrity defect that compromises sterile barrier maintenance. While the defect creates a risk of contamination and infection, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury are scored at 3 (High).
Plain-English summary
Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) is a sterile wound dressing used for moderate to heavily exuding wounds, including pressure ulcers, leg ulcers, cavity wounds, lacerations, and post-operative surgical wounds. Advanced Medical Solutions Ltd. is recalling approximately 3,900 boxes of the product.
The recall was issued because defects in the primary packaging pouch compromise the device's ability to maintain a sterile barrier. A compromised sterile barrier can allow contamination of the dressing, which could lead to infection when used on open wounds.
The affected dressing was distributed nationwide in the states of Illinois, Texas, and Virginia.
The recalled product
- Product
- Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
- Manufacturer
- Advanced Medical Solutions Ltd.
- Category
- Medical Device — Wound Dressing
- Hazard
- sterile-barrier-defect
- infection-risk
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)
- Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
Distribution
Distributed nationwide across the United States.
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