Reported Oct 26, 2022 · Ongoing
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral…
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
- REFa) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment
- Lot codes and dates
- a) 19211
- UDI
744 of 744 codes
(01)04026704347995(17)250528(10)19LT34(01)04026704347995(17)250528(10)20FT02(01)04026704347995(17)250528(10)20FT03(01)04026704347995(17)250528(10)20FT06(01)04026704347995(17)250528(10)20FT07(01)04026704347995(17)250528(10)20FT13(01)04026704347995(17)250528(10)20FT14(01)04026704347995(17)250528(10)20FT16(01)04026704347995(17)250528(10)20FT20(01)04026704347995(17)250528(10)20FT22(01)04026704347995(17)250528(10)20FT38(01)04026704347995(17)250528(10)20FT41(01)04026704347995(17)250528(10)20FT42(01)04026704347995(17)250528(10)20FT50(01)04026704347995(17)250528(10)20FT51(01)04026704347995(17)250528(10)20FT56(01)04026704347995(17)250528(10)20FT57(01)04026704347995(17)250528(10)20FT62(01)04026704347995(17)250528(10)20FT63(01)04026704347995(17)250628(10)20FT67(01)04026704347995(17)250628(10)20GT02(01)04026704347995(17)250628(10)20GT03(01)04026704347995(17)250628(10)20GT15(01)04026704347995(17)250628(10)20GT17(01)04026704347995(17)250628(10)20GT20(01)04026704347995(17)250628(10)20GT21(01)04026704347995(17)250628(10)20GT27(01)04026704347995(17)250628(10)20GT28(01)04026704347995(17)250628(10)20GT39(01)04026704347995(17)250628(10)20GT46(01)04026704347995(17)250628(10)20GT48(01)04026704347995(17)250628(10)20GT53(01)04026704347995(17)250628(10)20GT55(01)04026704347995(17)250628(10)KMH20G0002(01)04026704347995(17)250628(10)KMH20G0003(01)04026704347995(17)250628(10)KMH20G0004(01)04026704347995(17)250628(10)KMH20G0010(01)04026704347995(17)250628(10)KMH20G0011(01)04026704347995(17)250628(10)KMH20G0014(01)04026704347995(17)250628(10)KMH20G0017(01)04026704347995(17)250628(10)KMH20G0019(01)04026704347995(17)250628(10)KMH20G0026(01)04026704347995(17)250728(10)KMH20G0032(01)04026704347995(17)250728(10)KMH20H0005(01)04026704347995(17)250728(10)KMH20H0011(01)04026704347995(17)250728(10)KMH20H0015(01)04026704347995(17)250728(10)KMH20H0017(01)04026704347995(17)250728(10)KMH20H0019(01)04026704347995(17)250728(10)KMH20H0028(01)04026704347995(17)250728(10)KMH20H0035(01)04026704347995(17)250728(10)KMH20H0038(01)04026704347995(17)250728(10)KMH20H0053(01)04026704347995(17)250728(10)KMH20H0086(01)04026704347995(17)250728(10)KMH20H0099(01)04026704347995(17)250728(10)KMH20H0105(01)04026704347995(17)250728(10)KMH20H0112(01)04026704347995(17)250728(10)KMH20H0132(01)04026704347995(17)250728(10)KMH20H0159(01)04026704347995(17)250728(10)KMH20H0165(01)04026704347995(17)250728(10)KMH20H0167
- Amount recalled
- 60,500 units US
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.
Want the full recall guide?
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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