Recall Z-2314-2019
Teleflex Medical · initiated July 30, 2019
Class I – dangerous or defective products that could cause serious health problems or death
Product
Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211 g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112 h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113 i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114 j) 7.5 mm, REF 5-22215, REF 5-22315 k) 8.0 mm, REF 5-22216, REF 5-22316 l) 8.5 mm, REF 5-22217 m) 9.0 mm, REF 5-22218 Product Usage: Tracheal tube/airway management
Codes / lots: a) REF 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73G1800589 73G1800932 73L1800417 73L1800418 73M1800194 73M1800195 REF 5-22106 Batch numbers: 73E1700719 73M1700260 73E1800567 73J1800524 73K1800731 b) REF 5-22007 Batch numbers: 73L1600002 73K1700426 73A1800460 73D1800648 73E1800565 REF 5-22107 Batch numbers: 73L1600864 73F1700166 73E1800088 73K1800772 c) REF 5-22008 Batch numbers: 73C1700413 73F1700164 73G1700129 73J1700300 73A1800461 73B1800362 73F1800183 REF 5-22108 Batch numbers: 73K1600590 73M1600152 73A1700110 73D1700629 73F1700028 73B1800133 73E1800089 73G1800933 73J1800100 REF 5-22208 Batch numbers: 73L1600360 73A1700112 73D1700258 73F1700032 73F1700725 73G1700605 73H1700786 73J1700478 73K1700275 73K1700740 73L1700508 73M1700263 73A1800316 73A1800816 73B1800493 73C1800365 73D1800147 73E1800091 73E1800569 73F1800557 73H1800679 d) REF 5-22009 Batch numbers: 73L1600003 73C1700414 73D1700640 73F1700026 73G1700130 73H1700610 73K1700274 73A1800066 73C1800464 73D1800649 73E1800566 73F1800340 73L1800633 73L1800822 REF 5-22109 Batch numbers: 73L1600160 73L1600865 73M1600153 73A1700275 73B1700310 73C1700563 73D1700423…
Reason for recall
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
FDA-determined cause: Process control
Action taken
Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Details
- Recall number
- Z-2314-2019
- Initiated
- July 30, 2019
- Posted by FDA
- September 9, 2019
- Terminated
- February 15, 2022
- Product code
- BTR – Tube, Tracheal (W/Wo Connector)
- Quantity
- 278142 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Teleflex Medical, Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2311-2019 Class I | Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2312-2019 Class I | Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c)…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2313-2019 Class I | Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2315-2019 Class I | Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2316-2019 Class I | Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2317-2019 Class I | Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway managementReported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |
| Z-2318-2019 Class I | Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF…Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector… | 07/30/2019Terminated |