| Class 2 Device Recall | |
Date Initiated by Firm | March 01, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on September 01, 2005 |
Recall Number | Z-0757-04 |
Recall Event ID |
28428 |
Product Classification |
Blood Pressure Cuff - Product Code DXQ
|
Product | NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY. |
Code Information |
Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only) |
Recalling Firm/ Manufacturer |
Welch Allyn Inc 4341 State Street Rd Skaneateles Falls NY 13153-5300
|
For Additional Information Contact | John Sawyer 315-685-4571 |
Manufacturer Reason for Recall | GMP deficiencies |
FDA Determined Cause 2 | Other |
Action | Letters dated 3/1/2004 to customers with instructions to return product. Distributors instructed to notify their customers. |
Distribution | Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|