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RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced… recallZ-1124-2015 · Teleflex, Inc. · initiated Dec 12, 2014

Class II Terminated All recalls posted in February 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1124-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 12, 2014
Posted by the FDA
Feb 17, 2015
Recalling firm
Teleflex, Inc.
Quantity
2,292,361
Product code
BTR
FDA submissions
K990619
Distribution
Nationwide Distribution

Product description

RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

product codes: 103902-000035 103902-000040 103902-000045 103902-000050 103902-000055 103902-000060 103902-000065 103902-000070 103902-000075  lot numbers: 13EG10C 13FG15C 13FG34C 13GE30C 13IG03C 13IG31C 13JG22C 13KG11C 13LT18C 14AE04 14AE04C 14CE10 14CE11 14DG05 14FE23C 14HE34 13CG12 13EG11C 13FG03C 13FG32C 13GE29C 13HG16C 13IG15C 13IG31C 13IG32C 13IG34C 13JG14 13JG14C 13KE45 13KG08C 13KG11C 14AE05 14AE05C 14BG15 14BG30 14CE11 14DG05C 14HE34 14IE37C 14IE39 14IE39C 13FG03C 13FG32C 13GE29C 13IG12C 13JG12C 13JG14C 13KG11C 13KG31C 13LG35C 14AG22 14BG09 14CE10C 14CG22 14CG30 14DG07 14DG07C 14EG04 14EG07C 14EG32 14FE23C 14GE30 14HE33 14IE39C 14JG02C 14JG03 13BG28 13CG34C 13EG02C 13FG07C 13FG34C 13GE30C 13IG15C 13IG28C 13IG31C 13JG41 13KG21C 13KG31 14AT20 14CE11 14CG14C 14DG07 14DG13C 14ET22C 14FE23 14HG12 14HG12C 14IE39C 14IG18C 14JG02C 14JG03 13AG34 13BG28 13CG34C 13EG13C 13EG34C 13FG16C 13FG17C 13GE30C 13IG03C 13IG17 13IG18C 13IG28C 13JG22 13JG24 13KG22C 13LG13 14AG10C 14BG15 14BG23 14CE11C 14CG28C 13BG24 13EG02C 13EG36C 13FG32C 13GE30C 13IG16C 13IG20C 13IG31C 13JG12C 13JG14 13KG12C 13KG21C 13KG31 13LG32C 13LT18C 14AE05C 14AG10C 14AT20 14BG07 14BG21 14BG30 14BG30C 14CG28 14CG28C 14DG07 14EG05 14FE23C 14FG26C 14HE33C 14HG11 14IE37C 14IE39C 14JG03 13BG08 13BG25 13CG12 13CG33C 13EG02C 13EG13C 13FG14C 13FG32C 13GE30C 13GG42C 13HE34C 13HG24C 13HT16C 13IG16C 13IG17C 13IG32C 13IG34C 13JG13C 13JG14 13KG11C 13KG20C 13KG21 13LE50C 13LG11 13LG11C 13LG13C 13LG32 13LG32C 14AE05C 14AG22 14CG14C 14DG13C 14FE23C 14FG26C 14HE33C 14HE34C 13JG41 13KG20 13LG12 14AE04 14AG10 14BG13 14BG21 14CG14 14CG22 14DG05 14DG17 14DT03 14EG04 14EG31 14FG18 14FT04 14GE30 14GG30 14IE39 13IG15 13JG22 13JG41 13JG43 13KG31 13LG36 14AG10 14BG07 14BG21 14CE10 14CG30 14EG04 14EG05 14EG32 14GE30 14HG10 14IE37 14JG09 13JG22 13KG11 13LT18 14EG28 14FG26 14HE34 13IG34 14AE05 14EG05 14GG10 14GG30 14HE34 13JG14 14AG22 14EG28 14GE30 14GG09 14IG13 13JG22 14BG09 14DG05 14GG10 14IE39 13JG22 13JG24 14BG23 13JG12 14AT20 14CG28 14EG05 14FG24 14GG10 14IG12 14IG18 13IG34 14AG22 13JG12 13JG29 13KG20 14FG19 14FT04 14GG10 13JG22 14CG30 14FG18

Other devices under the same FDA submission

6 devices cleared under K990619 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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