Summary
The FDA issued a Class II for Pilling Wecksorb Cylindrical Sponges by TELEFLEX LLC. Reason: Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised..
Details
Source
Device Recall
External ID
Z-0772-2023
Action Date
2023-01-04
Status
Ongoing
Category
device
Product Description
Pilling Wecksorb Cylindrical Sponges
Lot/Code Info: Catalog Number: 200400, Lot Number: 22B0395
Quantity Affected: 1,000 units
Reason for Recall
Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.
Distribution
Domestic distribution to IL, MS, PA, TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-28
Company
Morrisville, NC
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 97 device recalls issued in the same week, part of 413 device-related FDA actions this month.
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls.
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 (TELEFLEX LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TELEFLEX LLC have FDA actions?
TELEFLEX LLC has 139 FDA actions in our database, including 139 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0772-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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