Manual Resuscitator Bag Series: AF1000 — Class I medical device recall Z-1948-2014
Terminated recall by Ventlab LLC, reported 2014-07-09, distributed nationwide. The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force
| Recall number | Z-1948-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ventlab LLC, Grand Rapids, MI, United States |
| Recall initiated | 2014-05-16 |
| Classified | 2014-07-03 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 251,384 |
| Lot numbers | 101441, 106245, 107029, 107291, 107315, 107461, 107609, 107634, 200349, 200492, 99523, AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1000, PRO-1900, PRO-2000, S105147, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN2002, VN2102, VN3000, VN4000, VN5000 |
Product
Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002. Emergency manual resuscitator for the Pediatric Population.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1948-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.