Iso-Gard Filter S with Expandi-Flex/Elbow: a) recall
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
Why was Iso-Gard Filter S with Expandi-Flex/Elbow: a) recalled?
Incidents of device splitting or detaching during use
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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
- Recalling firm
- TELEFLEX LLC
- Quantity
- 42 units
- Distribution
- US nationwide distribution
- Recall date
- October 26, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)