Class 1 Device Recall A Gibeck Product, IsoGard

• Date Initiated by Firm: August 29, 2022
• Date Posted: October 14, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0072-2023
• Recall Event ID: 90816
• 510(K)Number: K965016
• Product Classification: Filter, bacterial, breathing-circuit - Product Code CAH
• Product: 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 and equipment.
• Code Information: a) 19211, UDI: (01)04026704347995(17)250528(10)19LT34, (01)04026704347995(17)250528(10)20FT02, (01)04026704347995(17)250528(10)20FT03, (01)04026704347995(17)250528(10)20FT06, (01)04026704347995(17)250528(10)20FT07, (01)04026704347995(17)250528(10)20FT13, (01)04026704347995(17)250528(10)20FT14, (01)04026704347995(17)250528(10)20FT16, (01)04026704347995(17)250528(10)20FT20, (01)04026704347995(17)250528(10)20FT22, (01)04026704347995(17)250528(10)20FT38, (01)04026704347995(17)250528(10)20FT41, (01)04026704347995(17)250528(10)20FT42, (01)04026704347995(17)250528(10)20FT50, (01)04026704347995(17)250528(10)20FT51, (01)04026704347995(17)250528(10)20FT56, (01)04026704347995(17)250528(10)20FT57, (01)04026704347995(17)250528(10)20FT62, (01)04026704347995(17)250528(10)20FT63, (01)04026704347995(17)250628(10)20FT67, (01)04026704347995(17)250628(10)20GT02, (01)04026704347995(17)250628(10)20GT03, (01)04026704347995(17)250628(10)20GT15, (01)04026704347995(17)250628(10)20GT17, (01)04026704347995(17)250628(10)20GT20, (01)04026704347995(17)250628(10)20GT21, (01)04026704347995(17)250628(10)20GT27, (01)04026704347995(17)250628(10)20GT28, (01)04026704347995(17)250628(10)20GT39, (01)04026704347995(17)250628(10)20GT46, (01)04026704347995(17)250628(10)20GT48, (01)04026704347995(17)250628(10)20GT53, (01)04026704347995(17)250628(10)20GT55, (01)04026704347995(17)250628(10)KMH20G0002, (01)04026704347995(17)250628(10)KMH20G0003, (01)04026704347995(17)250628(10)KMH20G0004, (01)04026704347995(17)250628(10)KMH20G0010, (01)04026704347995(17)250628(10)KMH20G0011, (01)04026704347995(17)250628(10)KMH20G0014, (01)04026704347995(17)250628(10)KMH20G0017, (01)04026704347995(17)250628(10)KMH20G0019, (01)04026704347995(17)250628(10)KMH20G0026, (01)04026704347995(17)250728(10)KMH20G0032, (01)04026704347995(17)250728(10)KMH20H0005, (01)04026704347995(17)250728(10)KMH20H0011, (01)04026704347995(17)250728(10)KMH20H0015, (01)04026704347995(17)250728(10)KMH20H0017, (01)04026704347995(17)250728(10)KMH20H0019, (01)04026704347995(17)250728(10)KMH20H0028, (01)04026704347995(17)250728(10)KMH20H0035, (01)04026704347995(17)250728(10)KMH20H0038, (01)04026704347995(17)250728(10)KMH20H0053, (01)04026704347995(17)250728(10)KMH20H0086, (01)04026704347995(17)250728(10)KMH20H0099, (01)04026704347995(17)250728(10)KMH20H0105, (01)04026704347995(17)250728(10)KMH20H0112, (01)04026704347995(17)250728(10)KMH20H0132, (01)04026704347995(17)250728(10)KMH20H0159, (01)04026704347995(17)250728(10)KMH20H0165, (01)04026704347995(17)250728(10)KMH20H0167, (01)04026704347995(17)250728(10)KMH20H0174, (01)04026704347995(17)250728(10)KMH20H0179, (01)04026704347995(17)250728(10)KMH20H0180, (01)04026704347995(17)250728(10)KMH20H0182, (01)04026704347995(17)250728(10)KMH20H0184, (01)04026704347995(17)250728(10)KMH20H0189, (01)04026704347995(17)250728(10)KMH20H0194, (01)04026704347995(17)250728(10)KMH20H0229, (01)04026704347995(17)250728(10)KMH20H0231, 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• Recalling Firm/ Manufacturer: TELEFLEX LLC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: Incidents of device splitting or detaching during use
• FDA Determined 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 in Commerce: 60,500 units US
• Distribution: US nationwide distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CAH