Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to he
Summary
The FDA issued a Class II for Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dr by Advanced Medical Solutions Ltd.. Reason: Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier..
Details
Source
Device Recall
External ID
Z-0617-2025
Action Date
2024-12-11
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Model Number: 529937R UDI-DI code: 0060075029530 Lot Number: W00070134
Quantity Affected: 3900 boxes
Reason for Recall
Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
Distribution
U.S. Nationwide distribution in the states of IL, TX, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-01
Company
Winsford
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Advanced Medical Solutions Ltd. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Advanced Medical Solutions Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Advanced Medical Solutions Ltd. have FDA actions?
Advanced Medical Solutions Ltd. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0617-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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