510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1940-2009

Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for...

Teleflex Medical / initiated 2009-07-31 / Terminated / root cause: manufacturing process
FDA source (opens on fda.gov)

Teleflex Medical began a recall of Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for... on . The reason FDA records is "The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1940-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Teleflex Medical
Product
Hudson RICA Sher-I-Swiv & Sher-I-Swiv F/O, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for use in thoracic surgery, bronchospirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes.
Product code
BZA Connector, Airway (Extension)
Reason for recall
The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.
Quantity in commerce
569,465 (total for all types)
Distribution
U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, New Zealand, France, Germany, Ireland, Sweden, Costa Rica, Puerto Rico, Jamaica, Brazil, Argentina, Uruguay and Colombia).
Product codes and lots
Catalog Number: 5-15301, Lot Numbers: 1132962, 1135424, 1136773, 1169645, 1173522, 1178399, 1188200, 1186993, 1194489,1201020, 1212344, 1258338, 1269036, 01L0700243, 01A0800245, 01C0800104, 01E0800341, 01F0800283, 01F0800354, 01L0800005, 01M0800250 and 01A0900036; and   Catalog Number: 5-15401, Lot Numbers: 1152620, 1153518, 1153626, 1155031, 1156400, 1156986, 1157666, 1160298, 1164076, 1169644, 1168080, 1172007, 1173521, 1182297, 1186762, 1193750, 1195118, 1276554, X1198365, X1198635, 01B0800103, 01F0800284, 01G0800362, 01H0800175, 01J0800015, 01A0900367 and 01D0900087.