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Lifesaver Single Patient Use Manual Resuscitator recallZ-1809-2015 · Teleflex Medical · initiated May 14, 2015

Class I Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The intake port may be blocked which can cause the bag to fail to fill.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1809-2015
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
May 14, 2015
Posted by the FDA
Jun 24, 2015
Recalling firm
Teleflex Medical
Quantity
9,333 units
Product code
BTM
FDA submissions
K964719
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 description

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.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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.

Other devices under the same FDA submission

2 devices cleared under K964719 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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