TELEFLEX LLC: 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

Recall number

Z-0076-2023

Recalling firm

TELEFLEX LLC

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

Status

Open, Classified

Initiated

2022-08-29

Posted

2022-10-14

Terminated

not on file

Reason

Incidents of device splitting or detaching during use

Root cause

Under Investigation by firm

Action

Teleflex, Inc. sent an URGENT MEDICAL DEVICE RECALL notice by Fedex 2-day mail on 08/29/2022. the notice described the problem, listed the complaints and requested the following actions be taken: Medical facilities: 1. Immediately check your inventory for product within the scope of this recall. Cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have impacted product, mark the applicable checkbox on the Acknowledgement Form and contact Teleflex Customer Service by calling the phone number provided. Teleflex Customer Service will issue a return goods authorization (RGA) number to you. Write the RGA number in the Acknowledgement Form and return form by email to Recalls@teleflex.com. 3. If you do not have impacted product, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex at Recalls@teleflex.com. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Distributors: 1. Provide this recall notice to all customers who have received impacted product. Each of your customers must complete the Acknowledgement Form and return it to you. 2. Immediately check your inventory for impacted product. Cease use and distribution of impacted product and immediately quarantine the affected product. You may return all product in scope. 3. As a distributor, you must confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to Teleflex Customer Service. Important - Please ensure you only list batch numbers in scope of this recall notice when completing this form. 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by email to Recalls@teleflex.com On October 28, 2022, the firm sent an updated recall notice with the expansion to additional

Quantity

42 units

Distribution

US nationwide distribution

Lot, serial or model codes

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.

510(k) numbers

["K965016"]

PMA numbers

not on file

Product code

CAH

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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