Recall Z-0756-04 ยท DXQ Blood Pressure Cuff
Welch Allyn Inc
NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114S - Allegiance Healthcare Corp., McGaw Park, I
| Date | Jul 20, 2004 (initiated Mar 1, 2004) |
| Status | Terminated |
| Reason | GMP deficiencies |
| Root cause | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.