Reported Oct 3, 2012 · Terminated
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX)
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa # 3 · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX)
32 of 32 products
| # | Product as published |
|---|---|
| 1 | Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB |
| 2 | A4403, 3F-80CM, SYNTEL RT-EMB |
| 3 | A4404, 4F-40CM, SYNTEL RT-EMB |
| 4 | A4405, 4F-80CM, SYNTEL RT-EMB |
| 5 | A4406, 5F-80CM, SYNTEL RT-EMB |
| 6 | A4407, 6F-80CM, SYNTEL RT-EMB |
| 7 | A4408, 7F-80CM, SYNTEL RT-EMB |
| 8 | A4F00, 2F-60CM (PREM) SYNTEL CATHETER |
| 9 | A4F01, 2F-80CM, (PREM) SYNTEL CATHETER |
| 10 | A4F02, 3F-40CM, (PREM) SYNTEL CATHETER |
| 11 | A4F03, 3F-80CM, (PREM) SYNTEL CATHETER |
| 12 | A4F04, 4F-40CM, (PREM) SYNTEL CATHETER |
| 13 | A4F05, 4F-80CM, (PREM) SYNTEL CATHETER |
| 14 | A4F06, 5F-80CM, (PREM) SYNTEL CATHETER |
| 15 | A4F07, 6F-80CM, (PREM) SYNTEL CATHETER |
| 16 | A4F08, 7F-80CM, (PREM) SYNTEL CATHETER |
| 17 | CE0260ST, L2F-60CM PREM SYNTEL CATH |
| 18 | CE0280ST, L2F-80CM PREM SYNTEL CATH |
| 19 | CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER |
| 20 | CE0380ST, 3F-80CM PREM SYNTEL CATH |
- Lot codes and dates
- Model NumbersLot
- Numbers A4402
115705411638041170473
- A4403
1157060116268911660311169109
- A4404
1160223116380311667251171181
- A4405
115521411570531161472116296711646281168912
- A4406
1155428116294511677451170042
- A4407
115447811628661168604
- A44081163626
- A4F00
116415211646271168666
- A4F01
1156256116000711636281168231
- A4F02
115652211617921170399
- A4F03
11558551157052116179311603101159725116321511639611167855116963211646261165853
- A4F04
1155427116022111617911156935117188311697291167751116577811633841172598
- A4F05
115585411544461156936115523011614711160222115941411619981163216116396211674401166463116462511653231168911
- A4F06
1155856115443511586241161997116414911657771169013
- A4F07
1171170115627111674141164151
- A4F08
11688551155648
- CE0260ST
11643071168569
- CE0280ST1164351
- CE0340ST1164348
- CE0380ST
116430811643371166033116902911662811166032
- CE0440ST
11643361168610
- CE0480ST
11643031164302116433511643041166468116860511662841166283
- CE0580ST
116434511643461168613
- CE0680ST
11643301166470
- CE0780ST1164354
- CE03401166904
- CE03801164344
- CE0440
11643471168609
- CE04801164343
- CE05801164349
- CE06801164353
- CE07801169926
- Amount recalled
- 40,238 units for all products in Recall Event
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Applied Medical Resources Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.