Summary
The FDA issued a Class II for Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor by TELEFLEX LLC. Reason: There are incomplete pre-cleaning instructions within the Instructions for Use (IFU)..
Details
Source
Device Recall
External ID
Z-2096-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
Lot/Code Info: Lot Numbers: C7, C8, C9, D5, D7, D9, E5, E8, G4, H8, I7, I9, J4, J6, K8, L3, L4, L6, L8, P1, S2, U0, V2, W1
Quantity Affected: 170 units
Reason for Recall
There are incomplete pre-cleaning instructions within the Instructions for Use (IFU).
Distribution
Nationwide and Australia, Canada, S. Korea, Singapore
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-25
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 287 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-2096-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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