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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63100

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

Open FDA event record

Event summary

Timeline bucket
August 09, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Applied Medical Resources Corp

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

3 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 3

Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB; A4F00, 2F-60CM (PREM) SYNTEL CATHETER; A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; CE0260ST, L2F-60CM PREM SYNTEL CATH; CE0280ST, L2F-80CM PREM SYNTEL CATH; CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; CE0380ST, 3F-80CM PREM SYNTEL CATH; CE0440ST, 4F-40CM PREM SYNTEL CATH; CE0480ST, 4F-80CM PREM SYNTEL CATH; CE0580ST, 5F-80CM PREM SYNTEL CATH; CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; CE0780ST, 7F-80CM PREM SYNTEL CATH; CE0340, 3F-40cm, SYNTEL RT-EMB; CE0380, 3F-80cm, SYNTEL RT-EMB; CE0440, 4F-40cm, SYNTEL RT-EMB; CE0480, 4F-80cm, SYNTEL RT-EMB; CE0580, 5F-80cm, SYNTEL RT-EMB; CE0680, 6F-80cm, SYNTEL RT-EMB; CE0780, 7F-80cm SYNTEL RT-EMB. BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

Z-2446-2012
Recall number
Z-2446-2012
Initiated
August 09, 2012
Classification
Class II
Status
Terminated
Quantity
40,238 units for all products in Recall Event

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Code information

Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

device · product 2 of 3

Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH; CB062313, SYNTEL BILIARY 6F-23CM CATH. Biliary Catheters are indicated for the removal of stones and ductal debris from the biliary system.

Z-2447-2012
Recall number
Z-2447-2012
Initiated
August 09, 2012
Classification
Class II
Status
Terminated
Quantity
40,238 units for all products in Recall Event

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Code information

Model Numbers: Lot Numbers A4752: 1165670. A4754: 1156762. A4762: 1155852, 1165674. CB052308: 1164350. CB054008: 1164305. CB062313: 1164306.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

device · product 3 of 3

Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

Z-2448-2012
Recall number
Z-2448-2012
Initiated
August 09, 2012
Classification
Class II
Status
Terminated
Quantity
40,238 units for all products in Recall Event

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.

Code information

Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.