Teleflex Medical: 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.

Recall number

Z-1942-2009

Recalling firm

Teleflex Medical

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.

Status

Terminated

Initiated

2009-07-31

Posted

2009-09-16

Terminated

2011-09-15

Reason

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

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

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).

Lot, serial or model codes

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.

510(k) numbers

["K850964"]

PMA numbers

not on file

Product code

BZA

Firm FEI

3005747797

Firm city

Durham

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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