Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

Class I - Dangerous

🏥 Medical Devices Recalled: August 29, 2022 TELEFLEX Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
a) 19012, UDI: (01)04026704400423(17)250528(10)KMZ21A0099; b) 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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: TELEFLEX LLC
Reason for Recall:: Incidents of device splitting or detaching during use
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

Product Codes/Lot Numbers:

a) 19012, UDI: (01)04026704400423(17)250528(10)KMZ21A0099; b) 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.