Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116).
Summary
The FDA issued a Class II for Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, by TELEFLEX LLC. Reason: Product may not be sterile.
Details
Source
Device Recall
External ID
Z-0227-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
Product Description
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Lot/Code Info: UDI (01)24026704323245(17)250405(10)74E2200810
Quantity Affected: 7200 catheters
Reason for Recall
Product may not be sterile
Distribution
TN, CA, NC, TX, FL, OH, MO, IL, OR
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-20
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 171 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-0227-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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