—#84077

Product

Hudson RICA Sheridan, ET Tube, Sher-I-Bronch RS, 28FR, 35 FR, 37 FR, 39FR and 41 FR, 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.

FDA product code: BZA — Connector, Airway (Extension)
Device class: Class 1
Medical specialty: Anesthesiology
510(k) numbers: K850964
Affected lot / code info: Catalog Number: 5-16128, Lot Numbers: 1169573, 1183453, 1186960, 1197168, 1205969, 1219532, 1233316, 1247807, 1256372, X1177389, 01K0800372 and 01D0900068; Catalog Number: 5-16135, Lot Numbers: 1138507, 1141035, 1145947, 1146249, 1148606, 1151231, 1152184, 1157033, 1169746, 1174454, 1176787, 1186981, 1190223, 1193745, 1198626, 1242901, 1256154, 1274788, 1279286, 1281124, 01K0700161, 01L0700414, 01A0800144, 01H0800280 and 01K0800146; Catalog Number: 5-16137, Lot Numbers: 1137695, 1140908, 1142035, 1144366, 1147062, 1148460, 1151236, 1152636, 1153628, 1154943, 1182363, 1187556, 1190332, 1192253, 1198625, 1241506, 1241616, 1244557, 1270823, 1278941, 1279287, X1158231, X1184238, X1189657, X49036, 01K0700357, 01L0700150, 01L0700226, 01E0800064, 01E0800132, 01E0800400, 01F0800057, 01F0800356, 01G0800167, 01K0800123, 01K0800384 and 01L0800167; Catalog Number: 5-16139, Lot Numbers: 1136908, 1141067, 1142803, 1155672, 1162104, 1163822, 1172148, 1175219, 1179997, 1183450, 1190333, 1192254, 1219531, 1247271, 1270822, 1273899, 01K0700060, 01K0700258, 01C0800327, 01E0800399, 01F0800192, 01K0800385 and 01A0900218; and Catalog Number: 5-16141, Lot Numbers: 1141964, 1162103, 1172149, 1185571, 1197167, X1176100 and 01C0800328.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: 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).

Timeline

Recall initiated: 2009-07-31
Posted by FDA: 2009-09-16
Terminated: 2011-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.