RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation

FDA device recall Z-1124-2015 · posted 2015-02-17 · Terminated

Recall details

Recalling firm

Teleflex, Inc.

Reason for recall

Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.

Action taken

Teleflex Medical sent an Urgent Medical Device Notification dated December 12, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please provide this Advisory Notice to all those who need to be aware of it within your organization. Please consider, clinicians, risk managers, supply chain/distribution centres, etc. in the circulation of this notice. There is no further action required. Clinical recommendation with regard to patient use is to continue the standard clinical practice of basing ET tube selection based on the tube size, carefully checking for the adequacy of ventilation and to change the ET tube size up or down as appropriate when intubating the patient. INSTRUCTION FOR DISTRIBUTORS OF AFFECTED PRODUCT If you are a distributor, provide this advisory notice to all of your customers who have received product in scope of this action. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Labeling mix-ups

Status

Terminated

Product code

BTR

Quantity affected

2,292,361

Distribution

Nationwide Distribution

Date initiated

2014-12-12

Date posted

2015-02-17

Date terminated

2015-07-30

Location

Wayne, PA

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