BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It ca
FDA device recall Z-2333-2010 · posted 2010-09-08 · Terminated
Recall details
- Recalling firm
- Westmed Inc
- Reason for recall
- This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.
- Action taken
- The firm, Westmed, sent a letter dated June 21, 2010, to all customers. The letter describes the product, problem and action to be taken by customer. The customers were instructed to cease distribution immediately, notify any facilities that they may have distributed the product identified of the recall, call Customer Service Manager at 1-800-975-7987 x 1223 and/or email kpeterson@westmedinc.com to receive Return Authorization to return identified product, and complete and return the enclosed Bag Easy Recall Reconciliation Checklist. If you have any question, contact Customer Service at 1-800-975-7987 or 1-520-294-7987.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 2,734
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-06-22
- Date posted
- 2010-09-08
- Date terminated
- 2011-03-22
- Location
- Tucson, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS (K940581) | Respironics, Inc. | 1994-05-06 |
| BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR (K934310) | Respironics, Inc. | 1993-12-14 |