Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000
FDA device recall Z-1948-2014 · posted 2014-07-03 · Terminated
Recall details
- Recalling firm
- Ventlab LLC
- Reason for recall
- The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
- Action taken
- The firm, Ventlab, issued a press dated May 14, 2014, stating Ventlab, LLC has initiated a voluntary medical device removal of a limited number of Ventlab" Resuscitator Bags. The bag series and lot numbers were included in a table as well as manufacture dates. In addition, Ventlab, LLC sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 19, 2014 to its distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to review and examine their inventory for affected product; stop using them and immediately contact Ventlab, LLC for further instructions on the return of these products; and if product was further distributed, identify their customers/consignees and notify them of this product removal. The customers were also instructed to complete and return the attached Return Response Form via fax at 1-800-400-8820, Attn: Quality Department, or email to: PFA@ventlab.com as soon as possible and inform all affected personnel of this removal. Ventlab will send new corrected replacement resuscitation bags to customers once you return the affected product. If you have any questions regarding this action, please call Ventlab at 1-800-237-5481 between the hours of 8:30 AM to 5:00 PM (EST) Monday through Friday, or 1-844-635-5326 or via e-mail at PFA@ventlab.com.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 251,384
- Distribution
- US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
- Date initiated
- 2014-05-16
- Date posted
- 2014-07-03
- Date terminated
- 2015-11-17
- Location
- Grand Rapids, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V*CARE MANUAL RESUSCITATOR (K012842) | Ventlab Corp. | 2001-09-18 |
| MANUAL RESUSCITATOR WITH ACE (K982215) | Medical Marketing Concepts | 1998-09-18 |
| MANUAL PULMONARY RESUSICITATOR (K953546) | Medical Marketing Concepts | 1996-02-29 |