FDA Medical Device Recalls (openFDA)
Ventlab Corporation: V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.
- Recall number
- Z-0982-03
- Recalling firm
- Ventlab Corporation
- Product
- V*CARE, Infant Resuscitator, with 40 cm HO Pressure Limiting System & Pressure Port Adapter, VN 3000 Series, Non-Sterile. The product included a clear plastic bag with white background which included Direction for Use statement #5. To remove vomitus: Disconnect resuscitator from patient. Tap the patient valve several times while squeezing the bag body. Retest the resuscitator for proper functioning. VentLab Corporation, 2934 Highway 601N, Mockville, NC 27028.
- Status
- Terminated
- Initiated
- 2003-04-15
- Posted
- 2003-07-08
- Terminated
- 2003-08-07
- Reason
- Printed bag with instructions to verify the pressure with a 'certified manometer' was omitted in some of the product.
- Root cause
- Other
- Action
- Consignee was notified by fax on 3/15/2003. All product on hand were returned to Ventlab.
- Quantity
- 9 cases (10 units per case)
- Distribution
- The product was distributed to one consignee in CA. The cases were returned to the recalling firm.
- Lot, serial or model codes
- Lot numbers 3332838D, 333238D5; Product Codes: VN3100OCP, VN3100MC, VN3100OCP-B, VN3100MCP-2 and VN3100OCB
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 1314417
- Firm city
- Mocksville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28