Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS… recallZ-0073-2023 · Teleflex LLC · initiated Aug 29, 2022

Why it was recalled

Incidents of device splitting or detaching during use

FDA root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 3. If you do not have impacted product, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex at [email protected]. 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 [email protected] On October 28, 2022, the firm sent an updated recall notice with the expansion to additional

Recall details

Recall number

Z-0073-2023

Status

Open, Classified

Initiated by the company

Aug 29, 2022

Posted by the FDA

Oct 14, 2022

Recalling firm

Teleflex LLC

Quantity

7 units

Product code

CAH

FDA submissions

K965016

Distribution

US nationwide distribution

Product description

Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

Other devices under the same FDA submission

1 device cleared under K965016 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• GIBECK IPN043751

  Teleflex Incorporated · Filter, bacterial, breathing-circuit
  2 recalls7 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 90816).

• Z-0072-2023 · Open, Classified
  Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient…
• Z-0074-2023 · Open, Classified
  Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
• Z-0075-2023 · Open, Classified
  Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
• Z-0076-2023 · Open, Classified
  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
• Z-0077-2023 · Open, Classified
  Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)