CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Centeze Centesis Catheter, 6F recalled by Galt Medical
Galt Medical is recalling Centeze Centesis Catheter, 6F, distributed in 9 states. The recall was initiated on 16 Nov 2020 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-0568-2021
- FDA event ID
- 86795
- Recalling firm
- Galt Medical, Garland, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2020
- FDA classified
- 14 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 16 Nov 2020 | Recall initiated by company | |
| 14 Dec 2020 | Classified by FDA | +28 days |
| 23 Dec 2020 | 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
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Product as listed by the FDA
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Where it was distributed
U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE
FloridaGeorgiaMassachusettsNorth CarolinaNew JerseyOhioPennsylvaniaPuerto RicoUtah
Questions about this recall
Why was it recalled?
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
Which lots are affected?
Catalog Number: DRC-002-06 Lot Numbers/UDI Code: 20108509/(01)0084 1268 100398(17)240428(10)20108509 20139676/(01)0084 1268 100398(11)200520(17)240519(10)20139676 20148911/(01)0084 1268 100398(11)200609(17)240608(10)20148911 20160253/(01)0084 1268 100398(11)200707(17)240706(10)20160253 20189100/(01)0084 1268 100398(11)200821(17)240820(10)20189100 Updated Information provided 03/16/2021: For Catalog Number: DRC-002-06 additional Lot Numbers: -20080351 -20234573 -20297230 -21008452 Additional Products: Catalog Number: DRC-006-16 Lot Numbers: -20217235 -20217236 -20217237
Where was it sold?
U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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