Z-2320-2021Class II

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c)...

Name: Z-2320-2021 RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c)...
Creator: Teleflex Medical Europe Ltd
Published: 2021-07-16
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2021-07-16 / Completed / root cause: manufacturing process

FDA source

Teleflex Medical Europe Ltd began a recall of RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f)... on 2021-07-16. FDA classified it as Class II and gives the reason as "The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2320-2021
Classification: Class II
Status: Completed
Initiated: 2021-07-16
Posted: 2021-08-19
Recalling firm: Teleflex Medical
Product: RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The firm received reports that the endotracheal tube cuff could be inflated while the pilot balloon remained flat.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter on 07/16/2021. The letter explained the issue and requested the return of the product. Distributors were directed to notify their customers.
Quantity in commerce: 155030 units
Distribution: US Nationwide distribution.
Product codes and lots: a) 504550, Lot Numbers: KME20K0001, KME20K0467, KME20K1581, KME20L0618, KME20L1090, KME20L2027, KME20M0019, KME21A2076, KME21A2787, KME21B1140, KME21C0059, KME21C2363 b) 504555, Lot Numbers: KME20K0765, KME20K0766, KME20K0935, KME20K1582, KME20L0619, KME20L1857, KME20L2028, KME20M0020, KME21A1902, KME21A2796, KME21B2681, KME21C2707 c) 504560, Lot Numbers: KME20K1550, KME20L0336, KME20L2298, KME20M0021, KME20M0492, KME21A0380, KME21A0817, KME21A1160, KME21A1770, KME21B1137, KME21B1138, KME21B1139, KME21C3255 d) 504565, Lot Numbers: KME20K0465, KME20K0939, KME20K1551, KME20K1628, KME20K2246, KME20L0488, KME20L1840, KME20M0022, KME20M0854, KME20M1102, KME20M1579, KME21A0085, KME21A1040, KME21A1292, KME21A2794, KME21B1141, KME21B1669, KME21B2155, KME21B2501, KME21B2502, KME21B2855, KME21C0025, KME21C1202, KME21C1331, KME21C1790, KME21C1897, KME21C2188, KME21C2262, KME21C2835 e) 504570, Lot Numbers: KME20K0026, KME20K0360, KME20K0361, KME20K0768, KME20K0941, KME20K1148, KME20K1202, KME20K1304, KME20K1552, KME20K1658, KME20K2057, KME20K2187, KME20K3161, KME20K3355, KME20L0057, KME20L0059, KME20L0490, KME20L0623, KME20L0943, KME20L0944, KME20L1091, KME20L1122, KME20L1124, KME20L1475, KME20L1844, KME20L2039, KME20L2258, KME20L2827, KME20M0378, KME20M0379, KME20M0380, KME20M0498, KME20M1105, KME20M1153, KME20M1156, KME21A0228, KME21A0273, KME21A0304, KME21A0305, KME21A1769, KME21A2227, KME21A2228, KME21A2229, KME21A2263, KME21A3119, KME21A3120, KME21A3121, KME21B0261, KME21B0338, KME21B0559, KME21B0750, KME21B1073, KME21B1751, KME21B2107, KME21B2153, KME21B2460, KME21B2719, KME21B2721, KME21C0123, KME21C0376, KME21C0421, KME21C0620, KME21C0634, KME21C1016, KME21C1333, KME21C1416, KME21C1434, KME21C1489, KME21C1593, KME21C1653, KME21C1703, KME21C1786, KME21C1896, KME21C2065, KME21C2146 f) 504575, Lot Numbers: KME20K0769, KME20K0770, KME20K1150, KME20K1204, KME20K1665, KME20K2188, KME20K2920, KME20K3016, KME20K3018, KME20K3159, KME20K3575, KME20L1476, KME20L2374, KME20M0383, KME20M1151, KME20M2051, KME20M2344, KME20M2376, KME20M2485, KME20M2556, KME21A0084, KME21A0303, KME21A0671, KME21A0672, KME21A0673, KME21A0674, KME21A0812, KME21A1041, KME21A1464, KME21A1605, KME21A2799, KME21A2815, KME21B0753, KME21B0814, KME21B0888, KME21B0889, KME21B0931, KME21B1240, KME21B2461, KME21B2462, KME21B2465, KME21B2716, KME21B2717, KME21C0700, KME21C0972, KME21C1203, KME21C1336, KME21C1435, KME21C1893, KME21C2565, KME21C2610 g) 504580, Lot Numbers: KME20K0449, KME20K0450, KME20K1414, KME20K2622, KME20L1277, KME20L1479, KME20L2302, KME20L2828, KME20M1752, KME20M1753, KME21A0381, KME21A0820, KME21A0823, KME21A1291, KME21A1604, KME21B0339, KME21B1241, KME21B1855, KME21B2108, KME21B2154, KME21B2697, KME21C0377, KME21C0623, KME21C2407, KME21C2738, KME21C3448 f) 504585, Lot Numbers: KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21A0891, KME21A1043, KME21A2802, KME21A2803, KME21B0933, KME21B1250, KME21B1251, KME21B2029, KME21C0506, KME21C2107, KME21C2339, KME21C2341, KME21C2553, KME21D0210 g) 504590, Lot Numbers: KME20L0626, KME20M0856, KME20M2091, KME21C0299, KME21C2104, KME21C2105

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2320-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2319-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-19
Z-2320-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-19
Z-2321-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-19
Z-2322-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-25	2021-08-19

Product code BTR

K961837Class IIRush Oral/nasal Tracheal Tube Cuffed Magill/murphyRusch Intl. / cleared 1996-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)