COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part
Summary
The FDA issued a Class II for COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IM by Cook Incorporated. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life..
Details
Source
Device Recall
External ID
Z-1791-2026
Action Date
2026-04-15
Status
Ongoing
Category
device
Product Description
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Lot/Code Info: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.
Quantity Affected: 104 units
Reason for Recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-05
Company
Bloomington, IN
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 232 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 clearances.
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 (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1791-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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