CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report
Reddick Scoop Tip Cholangiogram Stiffer Catheter recalled
LeMaitre Vascular is recalling LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper, distributed nationwide in the US. The recall was initiated on 7 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1453-2017
- FDA event ID
- 76476
- Recalling firm
- LeMaitre Vascular, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2017
- FDA classified
- 13 Mar 2017
- Reported
- 22 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Feb 2017 | Recall initiated by company | |
| 13 Mar 2017 | Classified by FDA | +34 days |
| 22 Mar 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) REF# 2401-53
Where it was distributed
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
Questions about this recall
Is Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) recalled?
Yes. LeMaitre Vascular recalled Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU) on 7 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1453-2017.
Why was it recalled?
The Contains Latex symbol was not printed onto the box label or the sterile (inner) product pouch
Which lots are affected?
Lot Number/Exp. Date: RST2413 2019-01
Where was it sold?
Worldwide distribution. US Nationwide, AUSTRIA, BELGIUM, FRANCE, GERMANY, ITALY, LUXEMBOURG, Morocco, Saudi Arabia, Singapore, SPAIN, SWITZERLAND, UAE, and UK
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from LeMaitre Vascular
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| Device | CLASS II | Artegraft Vascular Graft recalled by LeMaitre Vascular | LeMaitre Vascular | Packaging Defects | Nationwide |
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