Recall Z-0244-04 ยท DXQ Blood Pressure Cuff
Welch Allyn Inc
NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, 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 #5082-104-1 (10 pack/
| Date | Dec 18, 2003 (initiated Oct 27, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Letters dated October 27, 2003 to wholesalers/ distributors with instructions to remove/return product and notify end users. |
| Quantity | 26190 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.