Reported Oct 26, 2022 · Ongoing
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter,…
Teleflex LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TELEFLEX LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Iso-Gard Filter S, with Expandi-Flex
- REFa) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
- Lot codes and dates
- a) 19261
- UDI
(01)04026704388486(17)260128(10)KMH21B0193(01)04026704388486(17)251028(10)KMH20L0234(01)04026704388486(17)260828(10)KMH21J0246(01)04026704388486(17)261028(10)KMH21L0294(01)04026704388486(17)261228(10)KMH22A0230b) 19272
- UDI
(01)04026704388509(17)260428(10)KMZ21E0613(01)04026704388509(17)260528(10)KMZ21F0939
- Amount recalled
- 7 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Incidents of device splitting or detaching during use
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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