Z-2324-2008

Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags...

Name: Z-2324-2008 Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags...
Creator: Ventlab Corporation
Published: 2007-12-05
License: https://open.fda.gov/license/

Salter Labs / initiated 2007-12-05 / Terminated

FDA source

Ventlab Corporation began a recall of Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The... on 2007-12-05. The reason FDA records is "During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2324-2008
Status: Terminated
Initiated: 2007-12-05
Posted: 2008-09-20
Terminated: 2008-10-15
Recalling firm: Salter Labs
Product: Ventlab-assembled Anesthesia breathing bags. The recall involves 3 Liter, 2 Liter and 1 Liter latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk.
Product code: BTC Bag, Reservoir
Reason for recall: During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
FDA root cause: Other
Action: Medline Industries, Waukegan, IL was notified by letter titled URGENT - MEDICAL DEVICE RECALL on/about 12/05/2007. They were instructed to check their facility for any of the the affected product in inventory. If found they were advised to destroy and discard. They were to notify Ventlab of the disposition of the bags at their facility. Contact James Cochie at 336-753-5000 if you have questions.
Quantity in commerce: 571, 500 units
Distribution: IL
Product codes and lots: (NC Facility): Part #720057B (3 Liter bags), Lot #63069, 64872, 65226, 66781, 67068, 67068; Part #720058B (2 Liter bags), Lot#63660, 64877, 65225, 68752; Part #720059B (1Liter bags), Lot#63661, 64878, 65227. (China Facility): Part #720057B, Lot #3B0001, 3B0002, 3B0005, 3B0004, 3B0005; Part #720059B, Lot #1B0001, 1B0002, 1B0003; and Part #720058B, Lot #2B0002

Product code BTC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)