Z-1809-2015Class I

Lifesaver Single Patient Use Manual Resuscitator

Name: Z-1809-2015 Lifesaver Single Patient Use Manual Resuscitator
Creator: Teleflex Medical
Published: 2015-05-14
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2015-05-14 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port... on 2015-05-14. FDA classified it as Class I and gives the reason as "The intake port may be blocked which can cause the bag to fail to fill". 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-1809-2015
Classification: Class I
Status: Terminated
Initiated: 2015-05-14
Posted: 2015-06-24
Terminated: 2024-05-13
Recalling firm: Teleflex Medical
Product: Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: The intake port may be blocked which can cause the bag to fail to fill.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated May 14, 2015, to all consignees asking them to immediately discontinue distribution and quarantine the recalled product. The letter also requested a sub-recall of the product. The recall letter also included a response form which is to be returned to Teleflex by emailing it to [email protected] or fax it to 1-855-419-8507, Attn: Customer Service. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
Quantity in commerce: 9,333 units
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IA, KS, LA, MA, MI, MN, MS, MO, NE, NH, NY, NC, OH, OK, PA, RI, SD, TN, TX, VA, WA, including Puerto Rico and the countries of Australia, Bahamas, Canada, Guatemala, and Mexico.
Product codes and lots: Product Code 5361 - 6 Digit Lot No. 140514 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140616 4 Digit Lot No. 1425, 6 Digit Lot No. 140617 4 Digit Lot No. 1425; 6 Digit Lot No. 140621 4 Digit Lot No. 1425; 6 Digit Lot No. 140806 4 Digit Lot No. 1432; 6 Digit Lot No. 141103 4 Digit Lot No. 1445; 6 Digit Lot 141117 - No. 4 Digit Lot No. 1447; 6 Digit Lot No. 141201- 4 Digit Lot No. 1449; 6 Digit Lot No. 141224 - 4 Digit Lot No. 1452; 6 Digit Lot No. 141227 - 4 Digit Lot No. 1452; 6 Digit Lot No. 150112 - 4 Digit Lot No. 1503; Product Code 5362 - 6 Digit Lot No. 140504 - 4 Digit Lot No. 1419; 6 Digit Lot No. 140515 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140517 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140617 - 4 Digit Lot No. 1425; 6 Digit Lot No. 140621 - 4 Digit Lot 1425; No. 6 Digit Lot No. 140812 - 4 Digit Lot No. 1433; 6 Digit Lot No. 140819 - 4 Digit Lot No. 1434; 6 Digit Lot No. 140823 - 4 Digit Lot No. 1434; 6 Digit Lot No. 140929 - 4 Digit Lot No. 1440; 6 Digit Lot No. 141110 - 4 Digit Lot No. 1446; 6 Digit Lot No. 141115 - 4 Digit Lot No. 1446; 6 Digit Lot No. 141201 - 4 Digit Lot No. 1449; 6 Digit Lot No. 141214 - 4 Digit Lot No.1451; 6 Digit Lot No. 150112 4 Digit Lot No. 1503; Product Code 5364 6 Digit Lot No. 140507 - 4 Digit Lot No. 1419; 6 Digit Lot No. 140508 4 Digit Lot No. 1419; 6 Digit Lot No. 140514 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140608 - 4 Digit Lot No. 1424; 6 Digit Lot No. 140614 - 4 Digit Lot No. 1424; 6 Digit Lot No. 140623 - 4 Digit Lot No. 1426; 6 Digit Lot No. 14628 - 4 Digit Lot 1426 - No. 6 Digit Lot No. 140714 - 4 Digit Lot No. 1429; 6 Digit Lot No. 140719 - 4 Digit Lot No. 1429; 6 Digit Lot No. 14806 - 4 Digit Lot No. 1432; 6 Digit Lot No. 140809 4 Digit Lot No. 1432; Product Code 5466 6 Digit Lot No. 140520 - 4 Digit Lot No. 1421; 6 Digit Lot No. 140923 - 4 Digit Lot No. 1439; 6 Digit Lot No. 140924 - 4 Digit Lot No. 1439; Product Code 45362 - 6 Digit Lot No. 140317 - 4 Digit Lot No. 1412; 6 Digit Lot No. 140630 - 4 Digit Lot No. 1427; 6 Digit Lot No. 141013 - 4 Digit Lot No. 1442.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1809-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1809-2015	Class I	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-24

Product code BTM

K964719Class IIHudson Rci Lifesaver Single Patient Use Manual ResuscitatorHudson Respiratory Care, Inc. / cleared 1997-02-21

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)