—#196055

Product

Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use

FDA product code: CAH — Filter, Bacterial, Breathing-Circuit
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K965016
Affected lot / code info: a) 19211T, UDI: (01)04026704400478(17)250528(10)20FT38, (01)04026704400478(17)250628(10)20FT63, (01)04026704400478(17)250728(10)20GT03, (01)04026704400478(17)250828(10)KMH20H0303, (01)04026704400478(17)251028(10)KMH20J0148, (01)04026704400478(17)251028(10)KMH20L0135, (01)04026704400478(17)251028(10)KMH20L0137, (01)04026704400478(17)251128(10)KMH20L0362, (01)04026704400478(17)251128(10)KMH20M0236, (01)04026704400478(17)251128(10)KMH20M0276, (01)04026704400478(17)251228(10)KMH20M0477, (01)04026704400478(17)260228(10)KMH21A0397, (01)04026704400478(17)260828(10)KMH21C0228, (01)04026704400478(17)260928(10)KMH21J0146, (01)04026704400478(17)260928(10)KMH21K0122, (01)04026704400478(17)260928(10)KMH21K0130, (01)04026704400478(17)260928(10)KMH21K0133, (01)04026704400478(17)260928(10)KMH21K0137, (01)04026704348008(17)241128(10)KMH21K0155; b) 19212T, UDI: (01)04026704400485(17)250528(10)202025, (01)04026704400485(17)250528(10)202026, (01)04026704400485(17)250628(10)202027, (01)04026704400485(17)250628(10)202029, (01)04026704400485(17)250628(10)202030, (01)04026704400485(17)250728(10)KMZ20H0321, (01)04026704400485(17)250728(10)KMZ20H0341, (01)04026704400485(17)250728(10)KMZ20H0407, (01)04026704400485(17)250728(10)KMZ20H0519, (01)04026704400485(17)250728(10)KMZ20H0602, (01)04026704400485(17)250728(10)KMZ20H0619, (01)04026704400485(17)250728(10)KMZ20H0785, (01)04026704400485(17)250728(10)KMZ20H0792, (01)04026704400485(17)250728(10)KMZ20H0804, (01)04026704400485(17)250728(10)KMZ20H1025, (01)04026704400485(17)250728(10)KMZ20H1026, (01)04026704400485(17)250828(10)KMZ20J0386, (01)04026704400485(17)250828(10)KMZ20J0428, (01)04026704400485(17)250828(10)KMZ20J0466, (01)04026704400485(17)250828(10)KMZ20J0475, (01)04026704400485(17)250928(10)KMZ20K0161, (01)04026704400485(17)250928(10)KMZ20K0436, (01)04026704400485(17)250928(10)KMZ20K0478, (01)04026704400485(17)250928(10)KMZ20K0526, (01)04026704400485(17)250928(10)KMZ20K0527, (01)04026704400485(17)250928(10)KMZ20K0799, (01)04026704400485(17)250928(10)KMZ20K0917, (01)04026704400485(17)250928(10)KMZ20K1295, (01)04026704400485(17)250928(10)KMZ20K1311, (01)04026704400485(17)251028(10)KMZ20L0144, (01)04026704400485(17)251028(10)KMZ20L0160, (01)04026704400485(17)251028(10)KMZ20L0338, (01)04026704400485(17)251028(10)KMZ20L0350, (01)04026704400485(17)251028(10)KMZ20L0912, (01)04026704400485(17)251028(10)KMZ20L0926, (01)04026704400485(17)251028(10)KMZ20L0927, (01)04026704400485(17)251028(10)KMZ20L0928, (01)04026704400485(17)251028(10)KMZ20L0944, (01)04026704400485(17)251128(10)KMZ20M0411, (01)04026704400485(17)251128(10)KMZ20M1224, (01)04026704400485(17)251228(10)KMZ21A0011, (01)04026704400485(17)251228(10)KMZ21A0214, (01)04026704400485(17)251228(10)KMZ21A0301, (01)04026704400485(17)251228(10)KMZ21A0369, (01)04026704400485(17)251228(10)KMZ21A0419, (01)04026704400485(17)251228(10)KMZ21A0533, (01)04026704400485(17)251228(10)KMZ21A0807, (01)04026704400485(17)251228(10)KMZ21A0867, (01)04026704400485(17)251228(10)KMZ21A1017, (01)04026704400485(17)260128(10)KMZ21B0688, (01)04026704400485(17)260128(10)KMZ21B1032, (01)04026704400485(17)260128(10)KMZ21B1156, (01)04026704400485(17)260128(10)KMZ21B1188, (01)04026704400485(17)260228(10)KMZ21C0712, (01)04026704400485(17)260228(10)KMZ21C0760, (01)04026704400485(17)260228(10)KMZ21C0882, (01)04026704400485(17)260228(10)KMZ21C1163, (01)04026704400485(17)260228(10)KMZ21C1329, (01)04026704400485(17)260328(10)KMZ21D0390, (01)04026704400485(17)260328(10)KMZ21D0394, (01)04026704400485(17)260328(10)KMZ21D0400, (01)04026704400485(17)260328(10)KMZ21D0518, (01)04026704400485(17)260328(10)KMZ21D0534, (01)04026704400485(17)260328(10)KMZ21D1020, (01)04026704400485(17)260328(10)KMZ21D1051, (01)04026704400485(17)260428(10)KMZ21E0245, (01)04026704400485(17)260428(10)KMZ21E0253, (01)04026704400485(17)260428(10)KMZ21E0420, (01)04026704400485(17)260528(10)KMZ21F0202, (01)04026704400485(17)260528(10)KMZ21F0206, (01)04026704400485(17)260528(10)KMZ21F0217, (01)04026704400485(17)260528(10)KMZ21F0339, (01)04026704400485(17)260528(10)KMZ21F0438, (01)04026704400485(17)260528(10)KMZ21F0773, (01)04026704400485(17)260528(10)KMZ21F0786, (01)04026704400485(17)260628(10)KMZ21G0060, (01)04026704400485(17)260628(10)KMZ21G0353, (01)04026704400485(17)260628(10)KMZ21G0360, (01)04026704400485(17)260628(10)KMZ21G0392, (01)04026704400485(17)260728(10)KMZ21H0410, (01)04026704400485(17)260728(10)KMZ21H0424, (01)04026704400485(17)260728(10)KMZ21H0534, (01)04026704400485(17)260728(10)KMZ21H0538, (01)04026704400485(17)260828(10)KMZ21J0036, (01)04026704400485(17)260828(10)KMZ21J0321, (01)04026704400485(17)260828(10)KMZ21J0338, (01)04026704400485(17)260828(10)KMZ21J0403, (01)04026704400485(17)260828(10)KMZ21J0407, (01)04026704400485(17)260828(10)KMZ21J0428, (01)04026704400485(17)260828(10)KMZ21J0435, (01)04026704400485(17)260928(10)KMZ21K0028, (01)04026704400485(17)260928(10)KMZ21K0113, (01)04026704400485(17)260928(10)KMZ21K0191, (01)04026704400485(17)260928(10)KMZ21K0223, (01)04026704400485(17)260928(10)KMZ21K0230, (01)04026704400485(17)260928(10)KMZ21K0239, (01)04026704400485(17)260928(10)KMZ21K0260, (01)04026704400485(17)260928(10)KMZ21K0329, (01)04026704400485(17)260928(10)KMZ21K0381, (01)04026704400485(17)260928(10)KMZ21K0391, (01)04026704400485(17)260928(10)KMZ21K0403, (01)04026704400485(17)260928(10)KMZ21K0438, (01)04026704400485(17)260928(10)KMZ21K0457, (01)04026704400485(17)260928(10)KMZ21K0498, (01)04026704400485(17)260928(10)KMZ21K0552, (01)04026704400485(17)260928(10)KMZ21K0562, (01)04026704400485(17)260928(10)KMZ21K0579, (01)04026704400485(17)260928(10)KMZ21K0610, (01)04026704400485(17)261028(10)KMZ21L0114, (01)04026704400485(17)261028(10)KMZ21L0209, (01)04026704400485(17)261028(10)KMZ21L0321, (01)04026704400485(17)261028(10)KMZ21L0536, (01)04026704400485(17)261028(10)KMZ21L0665, (01)04026704400485(17)261128(10)KMZ21M0066, (01)04026704400485(17)261128(10)KMZ21M0476, (01)04026704400485(17)261128(10)KMZ21M0486, (01)04026704400485(17)261128(10)KMZ21M0526, (01)04026704400485(17)261128(10)KMZ21M0572, (01)04026704400485(17)261128(10)KMZ21M0586, (01)04026704400485(17)261128(10)KMZ21M0601, (01)04026704400485(17)261128(10)KMZ21M0606, (01)04026704400485(17)261128(10)KMZ21M0658, (01)04026704400485(17)261128(10)KMZ21M0742, (01)04026704400485(17)261128(10)KMZ21M0775, (01)04026704400485(17)261228(10)KMZ22A0035, (01)04026704400485(17)261228(10)KMZ22A0059, (01)04026704400485(17)261228(10)KMZ22A0076, (01)04026704400485(17)261228(10)KMZ22A0085, (01)04026704400485(17)261228(10)KMZ22A0471, (01)04026704400485(17)261228(10)KMZ22A0482, (01)04026704400485(17)261228(10)KMZ22A0483, (01)04026704400485(17)270128(10)KMZ22B0043, (01)04026704400485(17)270128(10)KMZ22B0044, (01)04026704400485(17)270128(10)KMZ22B0123, (01)04026704400485(17)270128(10)KMZ22B0439, (01)04026704400485(17)270128(10)KMZ22B0480, (01)04026704400485(17)270128(10)KMZ22B0783, (01)04026704400485(17)270128(10)KMZ22B0871, (01)04026704400485(17)270228(10)KMZ22C0231, (01)04026704400485(17)270228(10)KMZ22C0398, (01)04026704400485(17)270228(10)KMZ22C0444, (01)04026704400485(17)270228(10)KMZ22C0606, (01)04026704400485(17)270228(10)KMZ22C0611, (01)04026704400485(17)270228(10)KMZ22C0616, (01)04026704400485(17)270228(10)KMZ22C0624.

Why it was recalled

Incidents of device splitting or detaching during use

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Teleflex, Inc. sent an URGENT MEDICAL DEVICE RECALL notice by Fedex 2-day mail on 08/29/2022. the notice described the problem, listed the complaints and requested the following actions be taken: Medical facilities: 1. Immediately check your inventory for product within the scope of this recall. Cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have impacted product, mark the applicable checkbox on the Acknowledgement Form and contact Teleflex Customer Service by calling the phone number provided. Teleflex Customer Service will issue a return goods authorization (RGA) number to you. Write the RGA number in the Acknowledgement Form and return form by email to Recalls@teleflex.com. 3. If you do not have impacted product, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex at Recalls@teleflex.com. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Distributors: 1. Provide this recall notice to all customers who have received impacted product. Each of your customers must complete the Acknowledgement Form and return it to you. 2. Immediately check your inventory for impacted product. Cease use and distribution of impacted product and immediately quarantine the affected product. You may return all product in scope. 3. As a distributor, you must confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to Teleflex Customer Service. Important - Please ensure you only list batch numbers in scope of this recall notice when completing this form. 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by email to Recalls@teleflex.com On October 28, 2022, the firm sent an updated recall notice with the expansion to additional

Recalling firm

Firm: TELEFLEX LLC
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US nationwide distribution

Timeline

Recall initiated: 2022-08-29
Posted by FDA: 2022-10-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196055. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.