NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: || Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); || Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); || Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); || Allegiance Tactics #30502-113 (case of 40/2 tubes); || Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); || Welch Allyn Tycos/Allegiance #5082-241-16 || Firm on the label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corp., McGaw Park, IL 60085-6787 USA''. 의 리콜
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Blood Pressure Cuff - Product Code DXQ
원인
Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading.
조치
Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users.
The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates in Ireland, Australia, and South Africa.
제품 설명
NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: || Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); || Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); || Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); || Allegiance Tactics #30502-113 (case of 40/2 tubes); || Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); || Welch Allyn Tycos/Allegiance #5082-241-16 || Firm on the label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corp., McGaw Park, IL 60085-6787 USA''.