Z-1948-2014Class I

Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000...

Name: Z-1948-2014 Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000...
Creator: Ventlab LLC
Published: 2014-05-16
License: https://open.fda.gov/license/

Salter Labs / initiated 2014-05-16 / Terminated

FDA source

Ventlab LLC began a recall of Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900... on 2014-05-16. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1948-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-16
Posted: 2014-07-03
Terminated: 2015-11-17
Recalling firm: Salter Labs
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.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
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.
FDA root cause: Process change control
Action: 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: [email protected] 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 [email protected].
Quantity in commerce: 251,384
Distribution: US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
Product codes and lots: Manual Resuscitator Bag Series: AF1000, AF2000, AF5000, BT4000, VN2000, VN5000, VT1000; Lot #s105147 -107609. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, PRO-1900, SC7000, SC8120, SS3200, VN2000, VN3000, VN4000, VN5000; Lot #s 106245 -107291. VN2102; Lot #200349. AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM2000, CPRM3000, PRO-1000, PRO-2000, SC7000, SC8020, VN2000, VN3000, VN4000; Lot #s 107029 -107634. VN2002; Lot # 200492. SC8000, SC9000; Lot #s 101441 -107461. CPRM1000; Lot #s 99523 -107315.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1948-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1948-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-03

Product code BTM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)