Reported Oct 26, 2022 · Ongoing
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial…
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/Elbowa) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
- Lot codes and dates
- a) 19012
- UDI
(01)04026704400423(17)250528(10)KMZ21A0099b) 19012T
- UDI
(01)04026704400423(17)250628(10)202025(01)04026704400423(17)250628(10)202027(01)04026704400423(17)250828(10)202028(01)04026704400423(17)250828(10)KMZ20J0079(01)04026704400423(17)251228(10)KMZ20J0861(01)04026704400423(17)251228(10)KMZ21A0100(01)04026704400423(17)251228(10)KMZ21A0127(01)04026704400423(17)251228(10)KMZ21A0238(01)04026704400423(17)251228(10)KMZ21A0425(01)04026704400423(17)251228(10)KMZ21A0427(01)04026704400423(17)251228(10)KMZ21A0522(01)04026704400423(17)251228(10)KMZ21A0535(01)04026704400423(17)251228(10)KMZ21A0617(01)04026704400423(17)251228(10)KMZ21A0712(01)04026704400423(17)251228(10)KMZ21A0828(01)04026704400423(17)251228(10)KMZ21A0854(01)04026704400423(17)251228(10)KMZ21A0860(01)04026704400423(17)251228(10)KMZ21A0909(01)04026704400423(17)260128(10)KMZ21A0926(01)04026704400423(17)260628(10)KMZ21B0141(01)04026704400423(17)260628(10)KMZ21G0174(01)04026704400423(17)260628(10)KMZ21G0180(01)04026704400423(17)260628(10)KMZ21G0181(01)04026704400423(17)260728(10)KMZ21G1067(01)04026704400423(17)260828(10)KMZ21H0277(01)04026704400423(17)260828(10)KMZ21J0069(01)04026704400423(17)260928(10)KMZ21J0386(01)04026704400423(17)260928(10)KMZ21K0208(01)04026704400423(17)260928(10)KMZ21K0648(01)04026704400423(17)260928(10)KMZ21K0707(01)04026704400423(17)261028(10)KMZ21K0856(01)04026704400423(17)261128(10)KMZ21L0309(01)04026704400423(17)261128(10)KMZ21M0061(01)04026704400423(17)261128(10)KMZ21M0492(01)04026704400423(17)261128(10)KMZ21M0493(01)04026704400423(17)270128(10)KMZ21M0813(01)04026704400423(17)270128(10)KMZ22B0105(01)04026704400423(17)270128(10)KMZ22B0117(01)04026704400423(17)270128(10)KMZ22B0118(01)04026704400423(17)270228(10)KMZ22B0508(01)04026704347995(17)241128(10)KMZ22C0622
- Amount recalled
- 42 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.
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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