FDA Device Recall Z-0044-2017: Teleflex Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2017.

Recall Res Number

Z-0044-2017

Recalling Firm / Manufacturer

Teleflex Medical

FEI Number

3005747797

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-08-26

Date Posted

2016-10-18

Date Terminated

2017-03-21

Product Code

JOH

Event Number

75053

Product Quantity

1095 units

Product Description Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.

Reason for Recall The connector may disconnect from the tracheostomy tube during use.

Action Details Teleflex sent an Urgent Field Safety Notice dated August 26, 2016, to all affected consignees. The letter requested that consignees cease use and distribution of stock, quarantine immediately, and return the product. Also, the letter requested a sub-recall if the product had been further distributed. The letter included an Acknowledgement Form which is to be returned. Customers with questions were instructed to contact their local sales representative or Customer Service. For questions regarding this recall call 610-378-0131.

Distribution Pattern Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey.

Code Information / Serial Numbers Lot - 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491

Related Establishments / Registrations

Sterigenics US LLC Registration: 1058584 View Registration
ICU Medical, Inc. Registration: 1219611 View Registration
BOSTON MEDICAL PRODUCTS, INC. Registration: 1219795 View Registration
Covidien Registration: 1219930 View Registration
SunMed Group Holdings, LLC Registration: 1314417 View Registration
Sterigenics U.S., LLC Registration: 1319639 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Cook Incorporated Registration: 1820334 View Registration
ICU Medical, Inc. Registration: 1824231 View Registration
MIDWEST STERILIZATION CORP. Registration: 1928237 View Registration
Sterigenics US LLC Registration: 2011171 View Registration
PASSY-MUIR, INC. Registration: 2024841 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
Sterigenics U.S., LLC Registration: 2219920 View Registration
CUSTOMED, INC. Registration: 2648727 View Registration
Covidien Registration: 2936999 View Registration
Synergy Health Ireland Ltd Registration: 3002807314 View Registration
MEDTRONIC B.V. (EOC) Registration: 3002807561 View Registration
ROSE GMBH FUER MEDIZINTECHNIK Registration: 3002808022 View Registration
HARWOOD DESIGN, INC. Registration: 3003761012 View Registration
Teleflex Medical de Mexico, S. de R.L. de C.V. Registration: 3004365956 View Registration
TYTEK MEDICAL INC Registration: 3004551550 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
Laboratorios PiSA, S. A. de C.V. Registration: 3007502289 View Registration
Sterigenics UK Limited Registration: 3008132398 View Registration
SAFEGUARD US OPERATING, LLC Registration: 3008258694 View Registration
SHIKANI MEDICAL LLC Registration: 3008278458 View Registration
ConvaTec Limited, GDC Building Registration: 3008806809 View Registration
HA2 MEDIZINTECHNIK GMBH Registration: 3009039068 View Registration
7051395 CANADA INC DBA HTA DIRECT SOURCING Registration: 3009518015 View Registration
OMNIMATE ENTERPRISE CO., LTD. Registration: 3009771213 View Registration
INTECHRITY INC Registration: 3009887154 View Registration
Teleflex LLC (NADC) Registration: 3010041511 View Registration
Synergy Sterilisation (M) Sdn Bhd Registration: 3010220595 View Registration
CYDONIA PHARMA SL Registration: 3011088743 View Registration
Teleflex Medical LLC Registration: 3011137372 View Registration
ICU Medical Czech Republic a. s. Registration: 3011237704 View Registration
DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration
ConvaTec, Inc. Registration: 3011987967 View Registration
ICU Medical, Inc. Registration: 3012307300 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
SANICURE BV Registration: 3012494290 View Registration
HI MEDICAL CO., LTD. Registration: 3012502601 View Registration
ICU Medical Nederland B.V. Registration: 3012542015 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
FOGLESS INTERNATIONAL AB Registration: 3014054118 View Registration
BURAK GLOBAL IC VE DIS TIC LTD STI Registration: 3014461810 View Registration
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Registration: 3014479313 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
RHENUS SE & CO. KG Registration: 3014656749 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration
Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
ICU Medical, Inc. Registration: 3027579175 View Registration
PLATINUM FOCUS GROUP LTD. Registration: 3030446844 View Registration
PHARMCO MEDICAL BV Registration: 3030447506 View Registration
PALM MEDICAL INTERNATIONAL BV Registration: 3030626857 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
BMMEDICAL Registration: 3031233007 View Registration
Pharmamed SA. Registration: 3037918935 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
GOODWILL COMMERCIAL SERVICES Registration: 3043337628 View Registration
TRACOE MEDICAL GMBH Registration: 8010485 View Registration
VBM MEDIZINTECHNIK GMBH Registration: 8010939 View Registration
Mallinckrodt Medical Registration: 8020889 View Registration
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. Registration: 8030673 View Registration
ATOS MEDICAL AB Registration: 8032044 View Registration
Teleflex Medical Sdn. Bhd. Registration: 8040412 View Registration
ICU Medical Healthcare Manufacturing S.A. de C.V. Registration: 9617604 View Registration
Covidien Registration: 9681384 View Registration

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Medical Device Recall: Z-0044-2017

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer