Exact FDA event identifier

Event 90816

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 29, 2022
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: TELEFLEX LLC

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.

Z-0072-2023

Recall number: Z-0072-2023
Initiated: August 29, 2022
Classification: Class I
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 60,500 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incidents of device splitting or detaching during use

Code information

a) 19211, UDI: (01)04026704347995(17)250528(10)19LT34, (01)04026704347995(17)250528(10)20FT02, (01)04026704347995(17)250528(10)20FT03, (01)04026704347995(17)250528(10)20FT06, (01)04026704347995(17)250528(10)20FT07, (01)04026704347995(17)250528(10)20FT13, (01)04026704347995(17)250528(10)20FT14, (01)04026704347995(17)250528(10)20FT16, (01)04026704347995(17)250528(10)20FT20, (01)04026704347995(17)250528(10)20FT22, (01)04026704347995(17)250528(10)20FT38, (01)04026704347995(17)250528(10)20FT41, (01)04026704347995(17)250528(10)20FT42, (01)04026704347995(17)250528(10)20FT50, (01)04026704347995(17)250528(10)20FT51, (01)04026704347995(17)250528(10)20FT56, (01)04026704347995(17)250528(10)20FT57, (01)04026704347995(17)250528(10)20FT62, (01)04026704347995(17)250528(10)20FT63, (01)04026704347995(17)250628(10)20FT67, (01)04026704347995(17)250628(10)20GT02, (01)04026704347995(17)250628(10)20GT03, (01)04026704347995(17)250628(10)20GT15, (01)04026704347995(17)250628(10)20GT17, (01)04026704347995(17)250628(10)20GT20, (01)04026704347995(17)250628(10)20GT21, (01)04026704347995(17)250628(10)20GT27, (01)04026704347995(17)250628(10)20GT28, (01)04026704347995(17)250628(10)20GT39, (01)04026704347995(17)250628(10)20GT46, (01)04026704347995(17)250628(10)20GT48, (01)04026704347995(17)250628(10)20GT53, (01)04026704347995(17)250628(10)20GT55, (01)04026704347995(17)250628(10)KMH20G0002, (01)04026704347995(17)250628(10)KMH20G0003, (01)04026704347995(17)250628(10)KMH20G0004, (01)04026704347995(17)250628(10)KMH20G0010, (01)04026704347995(17)250628(10)KMH20G0011, (01)04026704347995(17)250628(10)KMH20G0014, (01)04026704347995(17)250628(10)KMH20G0017, (01)04026704347995(17)250628(10)KMH20G0019, (01)04026704347995(17)250628(10)KMH20G0026, (01)04026704347995(17)250728(10)KMH20G0032, (01)04026704347995(17)250728(10)KMH20H0005, (01)04026704347995(17)250728(10)KMH20H0011, (01)04026704347995(17)250728(10)KMH20H0015, (01)04026704347995(17)250728(10)KMH20H0017, (01)04026704347995(17)250728(10)KMH20H0019, (01)04026704347995(17)250728(10)KMH20H0028, (01)04026704347995(17)250728(10)KMH20H0035, (01)04026704347995(17)250728(10)KMH20H0038, (01)04026704347995(17)250728(10)KMH20H0053, (01)04026704347995(17)250728(10)KMH20H0086, (01)04026704347995(17)250728(10)KMH20H0099, (01)04026704347995(17)250728(10)KMH20H0105, (01)04026704347995(17)250728(10)KMH20H0112, (01)04026704347995(17)250728(10)KMH20H0132, (01)04026704347995(17)250728(10)KMH20H0159, (01)04026704347995(17)250728(10)KMH20H0165, (01)04026704347995(17)250728(10)KMH20H0167, (01)04026704347995(17)250728(10)KMH20H0174, (01)04026704347995(17)250728(10)KMH20H0179, (01)04026704347995(17)250728(10)KMH20H0180, (01)04026704347995(17)250728(10)KMH20H0182, (01)04026704347995(17)250728(10)KMH20H0184, (01)04026704347995(17)250728(10)KMH20H0189, (01)04026704347995(17)250728(10)KMH20H0194, (01)04026704347995(17)250728(10)KMH20H0229, (01)04026704347995(17)250728(10)KMH20H0231, (01)04026704347995(17)250728(10)KMH20H0232, (01)04026704347995(17)250728(10)KMH20H0233, (01)04026704347995(17)250728(10)KMH20H0235, (01)04026704347995(17)250728(10)KMH20H0252, (01)04026704347995(17)250728(10)KMH20H0254, (01)04026704347995(17)250728(10)KMH20H0257, (01)04026704347995(17)250728(10)KMH20H0266, (01)04026704347995(17)250728(10)KMH20H0268, (01)04026704347995(17)250728(10)KMH20H0270, (01)04026704347995(17)250728(10)KMH20H0290, (01)04026704347995(17)250728(10)KMH20H0295, (01)04026704347995(17)250728(10)KMH20H0298, (01)04026704347995(17)250728(10)KMH20H0299, (01)04026704347995(17)250728(10)KMH20H0301, (01)04026704347995(17)250728(10)KMH20H0302, (01)04026704347995(17)250728(10)KMH20H0307, (01)04026704347995(17)250728(10)KMH20H0312, (01)04026704347995(17)250728(10)KMH20H0313, (01)04026704347995(17)250728(10)KMH20H0316, (01)04026704347995(17)250728(10)KMH20H0318, (01)04026704347995(17)250828(10)KMH20H0319, (01)04026704347995(17)250828(10)KMH20J0001, (01)04026704347995(17)250828(10)KMH20J0018, (01)04026704347995(17)250828(10)KMH20J0023, (01)04026704347995(17)250828(10)KMH20J0030, (01)04026704347995(17)250828(10)KMH20J0037, (01)04026704347995(17)250828(10)KMH20J0038, (01)04026704347995(17)250828(10)KMH20J0042, (01)04026704347995(17)250828(10)KMH20J0047, (01)04026704347995(17)250828(10)KMH20J0052, (01)04026704347995(17)250828(10)KMH20J0054, (01)04026704347995(17)250828(10)KMH20J0067, (01)04026704347995(17)250828(10)KMH20J0071, (01)04026704347995(17)250828(10)KMH20J0072, (01)04026704347995(17)250828(10)KMH20J0075, (01)04026704347995(17)250828(10)KMH20J0076, (01)04026704347995(17)250828(10)KMH20J0079, (01)04026704347995(17)250828(10)KMH20J0082, (01)04026704347995(17)250828(10)KMH20J0086, (01)04026704347995(17)250828(10)KMH20J0091, (01)04026704347995(17)250828(10)KMH20J0094, (01)04026704347995(17)250828(10)KMH20J0097, (01)04026704347995(17)250828(10)KMH20J0098, (01)04026704347995(17)250828(10)KMH20J0100, (01)04026704347995(17)250828(10)KMH20J0111, (01)04026704347995(17)250828(10)KMH20J0113, (01)04026704347995(17)250828(10)KMH20J0119, (01)04026704347995(17)250828(10)KMH20J0130, (01)04026704347995(17)250828(10)KMH20J0131, (01)04026704347995(17)250828(10)KMH20J0132, (01)04026704347995(17)250828(10)KMH20J0136, (01)04026704347995(17)250828(10)KMH20J0150, (01)04026704347995(17)250828(10)KMH20J0154, (01)04026704347995(17)250828(10)KMH20J0159, (01)04026704347995(17)250828(10)KMH20J0169, (01)04026704347995(17)250828(10)KMH20J0171, (01)04026704347995(17)250828(10)KMH20J0195, (01)04026704347995(17)250828(10)KMH20J0198, (01)04026704347995(17)250828(10)KMH20J0202, (01)04026704347995(17)250828(10)KMH20J0204, (01)04026704347995(17)250828(10)KMH20J0214, (01)04026704347995(17)250828(10)KMH20J0232, (01)04026704347995(17)250828(10)KMH20J0252, (01)04026704347995(17)250828(10)KMH20J0256, (01)04026704347995(17)250828(10)KMH20J0259, (01)04026704347995(17)250828(10)KMH20J0262, (01)04026704347995(17)250828(10)KMH20J0271, (01)04026704347995(17)250828(10)KMH20J0274, (01)04026704347995(17)250828(10)KMH20J0284, (01)04026704347995(17)250828(10)KMH20J0286, (01)04026704347995(17)250828(10)KMH20J0288, (01)04026704347995(17)250828(10)KMH20J0289, (01)04026704347995(17)250828(10)KMH20J0292, (01)04026704347995(17)250828(10)KMH20J0297, (01)04026704347995(17)250828(10)KMH20J0299, (01)04026704347995(17)250828(10)KMH20J0305, (01)04026704347995(17)250828(10)KMH20J0314, (01)04026704347995(17)250828(10)KMH20J0316, (01)04026704347995(17)250828(10)KMH20J0318, (01)04026704347995(17)250828(10)KMH20J0320, (01)04026704347995(17)250828(10)KMH20J0321, (01)04026704347995(17)250828(10)KMH20J0325, (01)04026704347995(17)250828(10)KMH20J0336, (01)04026704347995(17)250828(10)KMH20J0339, (01)04026704347995(17)250928(10)KMH20J0347, (01)04026704347995(17)250928(10)KMH20K0004, (01)04026704347995(17)250928(10)KMH20K0013, (01)04026704347995(17)250928(10)KMH20K0015, 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(01)04026704347995(17)260728(10)KMH21H0228, (01)04026704347995(17)260728(10)KMH21H0261, (01)04026704347995(17)260728(10)KMH21H0263, (01)04026704347995(17)260828(10)KMH21H0265, (01)04026704347995(17)260828(10)KMH21J0007, (01)04026704347995(17)260828(10)KMH21J0012, (01)04026704347995(17)260828(10)KMH21J0083, (01)04026704347995(17)260828(10)KMH21J0088, (01)04026704347995(17)260828(10)KMH21J0089, (01)04026704347995(17)260828(10)KMH21J0104, (01)04026704347995(17)260828(10)KMH21J0154, (01)04026704347995(17)260828(10)KMH21J0157, (01)04026704347995(17)260828(10)KMH21J0158, (01)04026704347995(17)260828(10)KMH21J0159, (01)04026704347995(17)260828(10)KMH21J0164, (01)04026704347995(17)260828(10)KMH21J0165, (01)04026704347995(17)260828(10)KMH21J0167, (01)04026704347995(17)260828(10)KMH21J0168, (01)04026704347995(17)260828(10)KMH21J0170, (01)04026704347995(17)260828(10)KMH21J0171, (01)04026704347995(17)260828(10)KMH21J0175, (01)04026704347995(17)260828(10)KMH21J0177, (01)04026704347995(17)260828(10)KMH21J0181, (01)04026704347995(17)260828(10)KMH21J0186, (01)04026704347995(17)260828(10)KMH21J0188, (01)04026704347995(17)260828(10)KMH21J0191, (01)04026704347995(17)260828(10)KMH21J0192, (01)04026704347995(17)260828(10)KMH21J0195, (01)04026704347995(17)260828(10)KMH21J0199, (01)04026704347995(17)260828(10)KMH21J0201, (01)04026704347995(17)260828(10)KMH21J0204, (01)04026704347995(17)260828(10)KMH21J0207, (01)04026704347995(17)260828(10)KMH21J0212, (01)04026704347995(17)260828(10)KMH21J0214, (01)04026704347995(17)260828(10)KMH21J0218, (01)04026704347995(17)260828(10)KMH21J0222, (01)04026704347995(17)260828(10)KMH21J0226, (01)04026704347995(17)260828(10)KMH21J0229, (01)04026704347995(17)260828(10)KMH21J0232, (01)04026704347995(17)260828(10)KMH21J0239, (01)04026704347995(17)260828(10)KMH21J0240, (01)04026704347995(17)260828(10)KMH21J0248, (01)04026704347995(17)260828(10)KMH21J0255, (01)04026704347995(17)260828(10)KMH21J0256, (01)04026704347995(17)260828(10)KMH21J0262, (01)04026704347995(17)260828(10)KMH21J0265, (01)04026704347995(17)260828(10)KMH21J0268, (01)04026704347995(17)260828(10)KMH21J0278, (01)04026704347995(17)260828(10)KMH21J0281, (01)04026704347995(17)260828(10)KMH21J0286, (01)04026704347995(17)260828(10)KMH21J0287, (01)04026704347995(17)260828(10)KMH21J0289, (01)04026704347995(17)260828(10)KMH21J0291, (01)04026704347995(17)260828(10)KMH21J0294, (01)04026704347995(17)260828(10)KMH21J0305, (01)04026704347995(17)260828(10)KMH21J0306, (01)04026704347995(17)260828(10)KMH21J0312, (01)04026704347995(17)260828(10)KMH21J0314, (01)04026704347995(17)260828(10)KMH21J0317, (01)04026704347995(17)260828(10)KMH21J0328, (01)04026704347995(17)260828(10)KMH21J0333, (01)04026704347995(17)260928(10)KMH21J0334, (01)04026704347995(17)260928(10)KMH21K0001, (01)04026704347995(17)260928(10)KMH21K0003, (01)04026704347995(17)260928(10)KMH21K0007, (01)04026704347995(17)260928(10)KMH21K0011, (01)04026704347995(17)260928(10)KMH21K0015, (01)04026704347995(17)260928(10)KMH21K0018, (01)04026704347995(17)260928(10)KMH21K0019, (01)04026704347995(17)260928(10)KMH21K0029, (01)04026704347995(17)260928(10)KMH21K0030, (01)04026704347995(17)260928(10)KMH21K0037, (01)04026704347995(17)260928(10)KMH21K0078, (01)04026704347995(17)260928(10)KMH21K0080, (01)04026704347995(17)260928(10)KMH21K0083, (01)04026704347995(17)260928(10)KMH21K0092, (01)04026704347995(17)260928(10)KMH21K0100, (01)04026704347995(17)260928(10)KMH21K0112, (01)04026704347995(17)260928(10)KMH21K0182, (01)04026704347995(17)260928(10)KMH21K0186, (01)04026704347995(17)260928(10)KMH21K0237, (01)04026704347995(17)260928(10)KMH21K0401, (01)04026704347995(17)260928(10)KMH21K0403, (01)04026704347995(17)260928(10)KMH21K0406, (01)04026704347995(17)260928(10)KMH21K0407, (01)04026704347995(17)260928(10)KMH21K0408, (01)04026704347995(17)261028(10)KMH21K0409, (01)04026704347995(17)261028(10)KMH21L0012, (01)04026704347995(17)261028(10)KMH21L0021, (01)04026704347995(17)261028(10)KMH21L0023, (01)04026704347995(17)261028(10)KMH21L0024, (01)04026704347995(17)261028(10)KMH21L0061, (01)04026704347995(17)261028(10)KMH21L0169, (01)04026704347995(17)261028(10)KMH21L0178, (01)04026704347995(17)261028(10)KMH21L0182, (01)04026704347995(17)261028(10)KMH21L0190, (01)04026704347995(17)261028(10)KMH21L0196, (01)04026704347995(17)261028(10)KMH21L0211, (01)04026704347995(17)261028(10)KMH21L0213, (01)04026704347995(17)261028(10)KMH21L0225, (01)04026704347995(17)261128(10)KMH21L0370, (01)04026704347995(17)261128(10)KMH21M0002, (01)04026704347995(17)261128(10)KMH21M0008, (01)04026704347995(17)261128(10)KMH21M0014, (01)04026704347995(17)261128(10)KMH21M0015, (01)04026704347995(17)261128(10)KMH21M0016, (01)04026704347995(17)261128(10)KMH21M0018, (01)04026704347995(17)261128(10)KMH21M0019, (01)04026704347995(17)261128(10)KMH21M0020, (01)04026704347995(17)261128(10)KMH21M0031, (01)04026704347995(17)261128(10)KMH21M0054, (01)04026704347995(17)261128(10)KMH21M0055, (01)04026704347995(17)261128(10)KMH21M0056, (01)04026704347995(17)261128(10)KMH21M0057, (01)04026704347995(17)261128(10)KMH21M0065, (01)04026704347995(17)261128(10)KMH21M0069, (01)04026704347995(17)261128(10)KMH21M0071, (01)04026704347995(17)261128(10)KMH21M0082, (01)04026704347995(17)261128(10)KMH21M0103, (01)04026704347995(17)261128(10)KMH21M0106, (01)04026704347995(17)261128(10)KMH21M0111, (01)04026704347995(17)261128(10)KMH21M0135, (01)04026704347995(17)261128(10)KMH21M0144, (01)04026704347995(17)261128(10)KMH21M0145, (01)04026704347995(17)26

Distribution pattern

US nationwide distribution

device · product 2 of 6

Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use

Z-0073-2023

Recall number: Z-0073-2023
Initiated: August 29, 2022
Classification: Class I
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 7 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incidents of device splitting or detaching during use

Code information

a) 19261, UDI: (01)04026704388486(17)260128(10)KMH21B0193, (01)04026704388486(17)251028(10)KMH20L0234, (01)04026704388486(17)260828(10)KMH21J0246, (01)04026704388486(17)261028(10)KMH21L0294, (01)04026704388486(17)261228(10)KMH22A0230; b) 19272, UDI: (01)04026704388509(17)260428(10)KMZ21E0613, (01)04026704388509(17)260528(10)KMZ21F0939

Distribution pattern

US nationwide distribution

device · product 3 of 6

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

Z-0074-2023

Recall number: Z-0074-2023
Initiated: August 29, 2022
Classification: Class I
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 164 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incidents of device splitting or detaching during use

Code information

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.

Distribution pattern

US nationwide distribution

device · product 4 of 6

Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,

Z-0075-2023

Recall number: Z-0075-2023
Initiated: August 29, 2022
Classification: Class I
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 355 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incidents of device splitting or detaching during use

Code information

a) 19261T, UDI: (01)04026704400492(17)250528(10)20FT51, (01)04026704400492(17)251028(10)KMH20L0409, (01)04026704400492(17)251228(10)KMH21A0086, (01)04026704400492(17)251228(10)KMH21A0190, (01)04026704400492(17)260128(10)KMH21B0163, (01)04026704400492(17)260128(10)KMH21B0343, (01)04026704400492(17)260128(10)KMH21B0355, (01)04026704400492(17)260228(10)KMH21C0177, (01)04026704400492(17)260228(10)KMH21C0387, (01)04026704400492(17)260528(10)KMH21F0156, (01)04026704400492(17)260528(10)KMH21F0337, (01)04026704400492(17)260628(10)KMH21G0426, (01)04026704400492(17)260828(10)KMH21J0020, (01)04026704400492(17)260828(10)KMH21J0245, (01)04026704400492(17)260928(10)KMH21K0142, (01)04026704400492(17)261128(10)KMH21M0182, (01)04026704400492(17)270128(10)KMH22B0151, (01)04026704400492(17)270128(10)KMH22B0248; b) 19262T, UDI: (01)04026704400508(17)250528(10)202025, (01)04026704400508(17)250528(10)202026, (01)04026704400508(17)250628(10)202030, (01)04026704400508(17)250828(10)KMZ20J0163, (01)04026704400508(17)250828(10)KMZ20J0171, (01)04026704400508(17)250828(10)KMZ20J0582, (01)04026704400508(17)250828(10)KMZ20J0586, (01)04026704400508(17)250828(10)KMZ20J0587, (01)04026704400508(17)250928(10)KMZ20K0681, (01)04026704400508(17)251028(10)KMZ20L0968, (01)04026704400508(17)251028(10)KMZ20L0977, (01)04026704400508(17)251028(10)KMZ20L1275, (01)04026704400508(17)251128(10)KMZ20M0544, (01)04026704400508(17)251128(10)KMZ20M0661, (01)04026704400508(17)251228(10)KMZ21A0175, (01)04026704400508(17)251228(10)KMZ21A0186, (01)04026704400508(17)251228(10)KMZ21A0187, (01)04026704400508(17)251228(10)KMZ21A0208, (01)04026704400508(17)260128(10)KMZ21B0483, (01)04026704400508(17)260128(10)KMZ21B0485, (01)04026704400508(17)260128(10)KMZ21B0495, (01)04026704400508(17)260128(10)KMZ21B0811, (01)04026704400508(17)260128(10)KMZ21B0918, (01)04026704400508(17)260128(10)KMZ21B1172, (01)04026704400508(17)260228(10)KMZ21C0884, (01)04026704400508(17)260228(10)KMZ21C0910, (01)04026704400508(17)260228(10)KMZ21C0929, (01)04026704400508(17)260228(10)KMZ21C0931, (01)04026704400508(17)260328(10)KMZ21D0419, (01)04026704400508(17)260528(10)KMZ21F0223, (01)04026704400508(17)260528(10)KMZ21F0260, (01)04026704400508(17)260528(10)KMZ21F0528, (01)04026704400508(17)260628(10)KMZ21G0728, (01)04026704400508(17)260628(10)KMZ21G0735, (01)04026704400508(17)260628(10)KMZ21G0739, (01)04026704400508(17)260728(10)KMZ21H0055, (01)04026704400508(17)260828(10)KMZ21J0006, (01)04026704400508(17)260828(10)KMZ21J0007, (01)04026704400508(17)260828(10)KMZ21J0008, (01)04026704400508(17)260928(10)KMZ21K0510, (01)04026704400508(17)260928(10)KMZ21K0524, (01)04026704400508(17)260928(10)KMZ21K0539, (01)04026704400508(17)260928(10)KMZ21K0572, (01)04026704400508(17)260928(10)KMZ21K0578, (01)04026704400508(17)260928(10)KMZ21K0592, (01)04026704400508(17)260928(10)KMZ21K0952, (01)04026704400508(17)261028(10)KMZ21L0218, (01)04026704400508(17)261128(10)KMZ21M0674, (01)04026704400508(17)270128(10)KMZ22B0125, (01)04026704400508(17)270128(10)KMZ22B0345, (01)04026704400508(17)270128(10)KMZ22B0809, (01)04026704400508(17)270128(10)KMZ22B0828, (01)04026704400508(17)270128(10)KMZ22B0838, (01)04026704400508(17)270128(10)KMZ22B0869, (01)04026704400508(17)270228(10)KMZ22C0659; c) 19272T, UDI: (01)04026704400515(17)250528(10)202025, (01)04026704400515(17)250528(10)202026, (01)04026704400515(17)250628(10)202027, (01)04026704400515(17)250628(10)202028, (01)04026704400515(17)250628(10)202029, (01)04026704400515(17)250628(10)202030, (01)04026704400515(17)250628(10)202031, (01)04026704400515(17)250628(10)KMZ20G0005, (01)04026704400515(17)250628(10)KMZ20G0026, (01)04026704400515(17)250628(10)KMZ20G0105, (01)04026704400515(17)250628(10)KMZ20G0112, (01)04026704400515(17)250728(10)KMZ20H0081, (01)04026704400515(17)250728(10)KMZ20H0096, (01)04026704400515(17)250728(10)KMZ20H0158, (01)04026704400515(17)250728(10)KMZ20H0379, (01)04026704400515(17)250728(10)KMZ20H0530, (01)04026704400515(17)250728(10)KMZ20H0540, (01)04026704400515(17)250728(10)KMZ20H0564, (01)04026704400515(17)250728(10)KMZ20H0812, (01)04026704400515(17)250728(10)KMZ20H0841, (01)04026704400515(17)250728(10)KMZ20H1021, (01)04026704400515(17)250728(10)KMZ20H1024, (01)04026704400515(17)250728(10)KMZ20H1031, (01)04026704400515(17)250828(10)KMZ20J0092, (01)04026704400515(17)250828(10)KMZ20J0102, (01)04026704400515(17)250828(10)KMZ20J0227, (01)04026704400515(17)250828(10)KMZ20J0441, (01)04026704400515(17)250828(10)KMZ20J0535, (01)04026704400515(17)250828(10)KMZ20J0551, (01)04026704400515(17)250828(10)KMZ20J0566, (01)04026704400515(17)250828(10)KMZ20J0640, (01)04026704400515(17)250828(10)KMZ20J0654, (01)04026704400515(17)250828(10)KMZ20J0663, (01)04026704400515(17)250828(10)KMZ20J0893, (01)04026704400515(17)250828(10)KMZ20J0958, (01)04026704400515(17)250928(10)KMZ20K0034, (01)04026704400515(17)250928(10)KMZ20K0196, (01)04026704400515(17)250928(10)KMZ20K0236, (01)04026704400515(17)250928(10)KMZ20K0430, (01)04026704400515(17)250928(10)KMZ20K0659, (01)04026704400515(17)250928(10)KMZ20K0662, (01)04026704400515(17)250928(10)KMZ20K0838, (01)04026704400515(17)250928(10)KMZ20K0946, (01)04026704400515(17)250928(10)KMZ20K1260, (01)04026704400515(17)250928(10)KMZ20K1289, (01)04026704400515(17)250928(10)KMZ20K1294, (01)04026704400515(17)250928(10)KMZ20K1310, (01)04026704400515(17)250928(10)KMZ20K1339, (01)04026704400515(17)250928(10)KMZ20K1340, (01)04026704400515(17)251028(10)KMZ20L0003, (01)04026704400515(17)251028(10)KMZ20L0030, (01)04026704400515(17)251028(10)KMZ20L0031, (01)04026704400515(17)251028(10)KMZ20L0117, (01)04026704400515(17)251028(10)KMZ20L0214, (01)04026704400515(17)251028(10)KMZ20L0351, (01)04026704400515(17)251028(10)KMZ20L0359, (01)04026704400515(17)251028(10)KMZ20L0499, (01)04026704400515(17)251028(10)KMZ20L0537, (01)04026704400515(17)251028(10)KMZ20L0706, (01)04026704400515(17)251028(10)KMZ20L0724, (01)04026704400515(17)251028(10)KMZ20L0885, (01)04026704400515(17)251028(10)KMZ20L0886, (01)04026704400515(17)251028(10)KMZ20L0933, (01)04026704400515(17)251028(10)KMZ20L0945, (01)04026704400515(17)251028(10)KMZ20L1056, (01)04026704400515(17)251028(10)KMZ20L1091, (01)04026704400515(17)251028(10)KMZ20L1103, (01)04026704400515(17)251028(10)KMZ20L1104, (01)04026704400515(17)251128(10)KMZ20M0387, (01)04026704400515(17)251128(10)KMZ20M0777, (01)04026704400515(17)251128(10)KMZ20M0778, (01)04026704400515(17)251128(10)KMZ20M0787, (01)04026704400515(17)251128(10)KMZ20M0822, (01)04026704400515(17)251128(10)KMZ20M0842, (01)04026704400515(17)251128(10)KMZ20M0938, (01)04026704400515(17)251128(10)KMZ20M0967, (01)04026704400515(17)251128(10)KMZ20M0990, (01)04026704400515(17)251128(10)KMZ20M1249, (01)04026704400515(17)251128(10)KMZ20M1250, (01)04026704400515(17)251128(10)KMZ20M1257, (01)04026704400515(17)251128(10)KMZ20M1267, (01)04026704400515(17)251228(10)KMZ21A0012, (01)04026704400515(17)251228(10)KMZ21A0024, (01)04026704400515(17)251228(10)KMZ21A0117, (01)04026704400515(17)251228(10)KMZ21A0126, (01)04026704400515(17)251228(10)KMZ21A0155, (01)04026704400515(17)251228(10)KMZ21A0162, (01)04026704400515(17)251228(10)KMZ21A0164, (01)04026704400515(17)251228(10)KMZ21A0203, (01)04026704400515(17)251228(10)KMZ21A0218, (01)04026704400515(17)251228(10)KMZ21A0226, (01)04026704400515(17)251228(10)KMZ21A0368, (01)04026704400515(17)251228(10)KMZ21A0618, (01)04026704400515(17)251228(10)KMZ21A0635, (01)04026704400515(17)251228(10)KMZ21A0693, (01)04026704400515(17)251228(10)KMZ21A0706, (01)04026704400515(17)251228(10)KMZ21A0714, (01)04026704400515(17)251228(10)KMZ21A0725, (01)04026704400515(17)251228(10)KMZ21A0734, (01)04026704400515(17)251228(10)KMZ21A0950, (01)04026704400515(17)260128(10)KMZ21B0101, (01)04026704400515(17)260128(10)KMZ21B0163, (01)04026704400515(17)260128(10)KMZ21B0181, (01)04026704400515(17)260128(10)KMZ21B0183, (01)04026704400515(17)260128(10)KMZ21B0185, (01)04026704400515(17)260128(10)KMZ21B0189, (01)04026704400515(17)260128(10)KMZ21B0227, (01)04026704400515(17)260128(10)KMZ21B0234, (01)04026704400515(17)260128(10)KMZ21B0305, (01)04026704400515(17)260128(10)KMZ21B0320, (01)04026704400515(17)260128(10)KMZ21B0417, (01)04026704400515(17)260128(10)KMZ21B0421, (01)04026704400515(17)260128(10)KMZ21B0435, (01)04026704400515(17)260128(10)KMZ21B0465, (01)04026704400515(17)260128(10)KMZ21B0471, (01)04026704400515(17)260128(10)KMZ21B0479, (01)04026704400515(17)260128(10)KMZ21B0533, (01)04026704400515(17)260128(10)KMZ21B0689, (01)04026704400515(17)260128(10)KMZ21B1171, (01)04026704400515(17)260228(10)KMZ21C0270, (01)04026704400515(17)260228(10)KMZ21C0388, (01)04026704400515(17)260228(10)KMZ21C0398, (01)04026704400515(17)260228(10)KMZ21C0883, (01)04026704400515(17)260228(10)KMZ21C1159, (01)04026704400515(17)260228(10)KMZ21C1160, (01)04026704400515(17)260228(10)KMZ21C1358, (01)04026704400515(17)260328(10)KMZ21D0420, (01)04026704400515(17)260528(10)KMZ21F0227, (01)04026704400515(17)260528(10)KMZ21F0265, (01)04026704400515(17)260528(10)KMZ21F0296, (01)04026704400515(17)260528(10)KMZ21F0335, (01)04026704400515(17)260528(10)KMZ21F0375, (01)04026704400515(17)260528(10)KMZ21F0430, (01)04026704400515(17)260528(10)KMZ21F0467, (01)04026704400515(17)260528(10)KMZ21F0468, (01)04026704400515(17)260528(10)KMZ21F0478, (01)04026704400515(17)260528(10)KMZ21F0501, (01)04026704400515(17)260528(10)KMZ21F0517, (01)04026704400515(17)260528(10)KMZ21F0534, (01)04026704400515(17)260528(10)KMZ21F0550, (01)04026704400515(17)260528(10)KMZ21F0551, (01)04026704400515(17)260528(10)KMZ21F0552, (01)04026704400515(17)260528(10)KMZ21F0557, (01)04026704400515(17)260528(10)KMZ21F0567, (01)04026704400515(17)260528(10)KMZ21F0568, (01)04026704400515(17)260528(10)KMZ21F0588, (01)04026704400515(17)260528(10)KMZ21F0594, (01)04026704400515(17)260528(10)KMZ21F0742, (01)04026704400515(17)260528(10)KMZ21F0777, (01)04026704400515(17)260628(10)KMZ21G0399, (01)04026704400515(17)260628(10)KMZ21G0403, (01)04026704400515(17)260628(10)KMZ21G0404, (01)04026704400515(17)260628(10)KMZ21G0751, (01)04026704400515(17)260628(10)KMZ21G0765, (01)04026704400515(17)260628(10)KMZ21G0770, (01)04026704400515(17)260628(10)KMZ21G0778, (01)04026704400515(17)260628(10)KMZ21G0786, (01)04026704400515(17)260628(10)KMZ21G0800, (01)04026704400515(17)260628(10)KMZ21G0806, (01)04026704400515(17)260628(10)KMZ21G0838, (01)04026704400515(17)260628(10)KMZ21G0911, (01)04026704400515(17)260628(10)KMZ21G0912, (01)04026704400515(17)260628(10)KMZ21G0917, (01)04026704400515(17)260628(10)KMZ21G0954, (01)04026704400515(17)260628(10)KMZ21G0955, (01)04026704400515(17)260628(10)KMZ21G0956, (01)04026704400515(17)260628(10)KMZ21G0964, (01)04026704400515(17)260628(10)KMZ21G0971, (01)04026704400515(17)260628(10)KMZ21G0982, (01)04026704400515(17)260628(10)KMZ21G0986, (01)04026704400515(17)260628(10)KMZ21G0992, (01)04026704400515(17)260628(10)KMZ21G0993, (01)04026704400515(17)260628(10)KMZ21G0995, (01)04026704400515(17)260628(10)KMZ21G1001, (01)04026704400515(17)260628(10)KMZ21G1008, (01)04026704400515(17)260628(10)KMZ21G1017, (01)04026704400515(17)260628(10)KMZ21G1037, (01)04026704400515(17)260628(10)KMZ21G1038, (01)04026704400515(17)260728(10)KMZ21H0115, (01)04026704400515(17)260728(10)KMZ21H0257, (01)04026704400515(17)260728(10)KMZ21H0299, (01)04026704400515(17)260728(10)KMZ21H0405, (01)04026704400515(17)260728(10)KMZ21H0429, (01)04026704400515(17)260728(10)KMZ21H0431, (01)04026704400515(17)260728(10)KMZ21H0433, (01)04026704400515(17)260728(10)KMZ21H0435, (01)04026704400515(17)260728(10)KMZ21H0504, (01)04026704400515(17)260728(10)KMZ21H0508, (01)04026704400515(17)260728(10)KMZ21H0526, (01)04026704400515(17)260728(10)KMZ21H0560, (01)04026704400515(17)260728(10)KMZ21H0561, (01)04026704400515(17)260828(10)KMZ21J0050, (01)04026704400515(17)260828(10)KMZ21J0077, (01)04026704400515(17)260828(10)KMZ21J0088, (01)04026704400515(17)260828(10)KMZ21J0089, (01)04026704400515(17)260828(10)KMZ21J0446, (01)04026704400515(17)260828(10)KMZ21J0447, (01)04026704400515(17)260828(10)KMZ21J0448, (01)04026704400515(17)260828(10)KMZ21J0484, (01)04026704400515(17)260828(10)KMZ21J0485, (01)04026704400515(17)260828(10)KMZ21J0534, (01)04026704400515(17)260828(10)KMZ21J0546, (01)04026704400515(17)260828(10)KMZ21J0554, (01)04026704400515(17)260828(10)KMZ21J0555, (01)04026704400515(17)260828(10)KMZ21J0570, (01)04026704400515(17)260828(10)KMZ21J0571, (01)04026704400515(17)260828(10)KMZ21J0579, (01)04026704400515(17)260828(10)KMZ21J0580, (01)04026704400515(17)260928(10)KMZ21K0045, (01)04026704400515(17)260928(10)KMZ21K0114, (01)04026704400515(17)260928(10)KMZ21K0163, (01)04026704400515(17)260928(10)KMZ21K0164, (01)04026704400515(17)260928(10)KMZ21K0266, (01)04026704400515(17)260928(10)KMZ21K0274, (01)04026704400515(17)260928(10)KMZ21K0295, (01)04026704400515(17)260928(10)KMZ21K0299, (01)04026704400515(17)260928(10)KMZ21K0308, (01)04026704400515(17)260928(10)KMZ21K0314, (01)04026704400515(17)260928(10)KMZ21K0318, (01)04026704400515(17)260928(10)KMZ21K0323, (01)04026704400515(17)260928(10)KMZ21K0452, (01)04026704400515(17)260928(10)KMZ21K0453, (01)04026704400515(17)260928(10)KMZ21K0509, (01)04026704400515(17)260928(10)KMZ21K0926, (01)04026704400515(17)260928(10)KMZ21K0953, (01)04026704400515(17)260928(10)KMZ21K0954, (01)04026704400515(17)261028(10)KMZ21L0047, (01)04026704400515(17)261028(10)KMZ21L0070, (01)04026704400515(17)261028(10)KMZ21L0074, (01)04026704400515(17)261028(10)KMZ21L0077, (01)04026704400515(17)261028(10)KMZ21L0079, (01)04026704400515(17)261028(10)KMZ21L0219, (01)04026704400515(17)261028(10)KMZ21L0220, (01)04026704400515(17)261028(10)KMZ21L0238, (01)04026704400515(17)261028(10)KMZ21L0239, (01)04026704400515(17)261028(10)KMZ21L0244, (01)04026704400515(17)261028(10)KMZ21L0295, (01)04026704400515(17)261028(10)KMZ21L0296, (01)04026704400515(17)261028(10)KMZ21L0307, (01)04026704400515(17)261028(10)KMZ21L0308, (01)04026704400515(17)261028(10)KMZ21L0316, (01)04026704400515(17)261028(10)KMZ21L0333, (01)04026704400515(17)261028(10)KMZ21L0334, (01)04026704400515(17)261028(10)KMZ21L0337, (01)04026704400515(17)261028(10)KMZ21L0344, (01)04026704400515(17)261028(10)KMZ21L0367, (01)04026704400515(17)261028(10)KMZ21L0368, (01)04026704400515(17)261028(10)KMZ21L0382, (01)04026704400515(17)261028(10)KMZ21L0389, (01)04026704400515(17)261028(10)KMZ21L0541, (01)04026704400515(17)261028(10)KMZ21L0798, (01)04026704400515(17)261028(10)KMZ21L0878, (01)04026704400515(17)261028(10)KMZ21L0880, (01)04026704400515(17)261028(10)KMZ21L0901, (01)04026704400515(17)261028(10)KMZ21L0924, (01)04026704400515(17)261128(10)KMZ21M0050, (01)04026704400515(17)261128(10)KMZ21M0690, (01)04026704400515(17)261128(10)KMZ21M0692, (01)04026704400515(17)261128(10)KMZ21M0719, (01)04026704400515(17)261128(10)KMZ21M0756, (01)04026704400515(17)261128(10)KMZ21M0781, (01)04026704400515(17)261128(10)KMZ21M0786, (01)04026704400515(17)261128(10)KMZ21M0790, (01)04026704400515(17)261128(10)KMZ21M0805, (01)04026704400515(17)261228(10)KMZ22A0635, (01)04026704400515(17)261228(10)KMZ22A0636, (01)04026704400515(17)261228(10)KMZ22A0650, (01)04026704400515(17)261228(10)KMZ22A0871, (01)04026704400515(17)270128(10)KMZ22B0130, (01)04026704400515(17)270128(10)KMZ22B0131, (01)04026704400515(17)270128(10)KMZ22B0192, (01)04026704400515(17)270128(10)KMZ22B0509, (01)04026704400515(17)270128(10)KMZ22B0524, (01)04026704400515(17)270128(10)KMZ22B0525, (01)04026704400515(17)270128(10)KMZ22B0556, (01)04026704400515(17)270128(10)KMZ22B0557, (01)04026704400515(17)270128(10)KMZ22B0784, (01)04026704400515(17)270128(10)KMZ22B0785, (01)04026704400515(17)270228(10)KMZ22C0395, (01)04026704400515(17)270228(10)KMZ22C0620, (01)04026704400515(17)270228(10)KMZ22C0802, (01)04026704400515(17)270228(10)KMZ22C0803.

Distribution pattern

US nationwide distribution

device · product 5 of 6

Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use

Z-0076-2023

Recall number: Z-0076-2023
Initiated: August 29, 2022
Classification: Class I
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incidents of device splitting or detaching during use

Code information

a) 19012, UDI: (01)04026704400423(17)250528(10)KMZ21A0099; b) 19012T, UDI: (01)04026704400423(17)250628(10)202025, (01)04026704400423(17)250628(10)202027, (01)04026704400423(17)250828(10)202028, (01)04026704400423(17)250828(10)KMZ20J0079, (01)04026704400423(17)251228(10)KMZ20J0861, (01)04026704400423(17)251228(10)KMZ21A0100, (01)04026704400423(17)251228(10)KMZ21A0127, (01)04026704400423(17)251228(10)KMZ21A0238, (01)04026704400423(17)251228(10)KMZ21A0425, (01)04026704400423(17)251228(10)KMZ21A0427, (01)04026704400423(17)251228(10)KMZ21A0522, (01)04026704400423(17)251228(10)KMZ21A0535, (01)04026704400423(17)251228(10)KMZ21A0617, (01)04026704400423(17)251228(10)KMZ21A0712, (01)04026704400423(17)251228(10)KMZ21A0828, (01)04026704400423(17)251228(10)KMZ21A0854, (01)04026704400423(17)251228(10)KMZ21A0860, (01)04026704400423(17)251228(10)KMZ21A0909, (01)04026704400423(17)260128(10)KMZ21A0926, (01)04026704400423(17)260628(10)KMZ21B0141, (01)04026704400423(17)260628(10)KMZ21G0174, (01)04026704400423(17)260628(10)KMZ21G0180, (01)04026704400423(17)260628(10)KMZ21G0181, (01)04026704400423(17)260728(10)KMZ21G1067, (01)04026704400423(17)260828(10)KMZ21H0277, (01)04026704400423(17)260828(10)KMZ21J0069, (01)04026704400423(17)260928(10)KMZ21J0386, (01)04026704400423(17)260928(10)KMZ21K0208, (01)04026704400423(17)260928(10)KMZ21K0648, (01)04026704400423(17)260928(10)KMZ21K0707, (01)04026704400423(17)261028(10)KMZ21K0856, (01)04026704400423(17)261128(10)KMZ21L0309, (01)04026704400423(17)261128(10)KMZ21M0061, (01)04026704400423(17)261128(10)KMZ21M0492, (01)04026704400423(17)261128(10)KMZ21M0493, (01)04026704400423(17)270128(10)KMZ21M0813, (01)04026704400423(17)270128(10)KMZ22B0105, (01)04026704400423(17)270128(10)KMZ22B0117, (01)04026704400423(17)270128(10)KMZ22B0118, (01)04026704400423(17)270228(10)KMZ22B0508, (01)04026704347995(17)241128(10)KMZ22C0622.

Distribution pattern

US nationwide distribution

device · product 6 of 6

Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

Z-0077-2023

Recall number: Z-0077-2023
Initiated: August 29, 2022
Classification: Class I
Status: Ongoing
Recalling firm: TELEFLEX LLC
Quantity: 12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Incidents of device splitting or detaching during use

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incidents of device splitting or detaching during use

Code information

UDI: (01)04026704561544(17)250728(10)KMH20H0092, (01)04026704561544(17)250728(10)KMH20H0109, (01)04026704561544(17)251028(10)KMH20L0312, (01)04026704561544(17)251028(10)KMH20L0344, (01)04026704561544(17)251128(10)KMH20M0237, (01)04026704561544(17)251228(10)KMH21A0033, (01)04026704561544(17)260128(10)KMH21B0197, (01)04026704561544(17)260328(10)KMH21D0181, (01)04026704561544(17)260828(10)KMH21J0103, (01)04026704561544(17)260828(10)KMH21J0150, (01)04026704561544(17)261228(10)KMH22A0181, (01)04026704561544(17)261228(10)KMH22A0185.

Distribution pattern

US nationwide distribution