Z-1892-2011

Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems, Nobleville, IN. An...

Name: Z-1892-2011 Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems, Nobleville, IN. An...
Creator: King Systems Corp.
Published: 2011-01-24
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2011-01-24 / Terminated / root cause: manufacturing process

FDA source

King Systems Corp. began a recall of Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose... on 2011-01-24. The reason FDA records is "The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1892-2011
Status: Terminated
Initiated: 2011-01-24
Posted: 2011-04-06
Terminated: 2012-08-14
Recalling firm: King Systems Corporation.
Product: Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems, Nobleville, IN. An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.
Product code: BYG Mask, Oxygen
Reason for recall: The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm issued an URGENT PRODUCT RECALL letter dated 1/24/2011. The letter identified the affected product and stated the reason for recall. The letter instructed consignees to cease all sales, to immediately examine their inventory, and to quarantine the product. The letter included a response form that is to be completed and returned. Distributors were instructed to inform their customers of the recall. King Systems Customer Service Department should be contacted at 1-800-642-5464 in order to receive a Return Authorization Number. The letter stated that consignees should return the recalled products to King Systems and the firm will replace the products or provide an acceptable substitute. Customers should contact Customer Service if they have any questions regarding the recall and the letter.
Quantity in commerce: 276 cases of 30 per case 8280 units
Distribution: Nationwide Distribution -- NM, GA, TX, FL, IL, VA and LA.
Product codes and lots: IMPQ5, IMXP7, IN158, IN657, IN9Y0, INGD2, INNX3, INYR8, IP6S9, IPH37, IPM99, IPV16, IQ117, IQBX9, IQLF1, IQXF0, IR883, IRIZ6, IRWL2, IS4Z1, ISB52.

Product code BYG

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)