smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Summary
The FDA issued a Class II for smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 1 by Smiths Medical ASD Inc.. Reason: Uncertainty in the seal integrity of the sterile packaging..
Details
Source
Device Recall
External ID
Z-0147-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
Product Description
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Lot/Code Info: a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; b) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; c) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057
Quantity Affected: 141,196 units
Reason for Recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-18
Company
Minneapolis, MN
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 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 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 (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD Inc. have FDA actions?
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0147-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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