CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report
Drainer Centesis Catheter, Sterile EO recalled by Galt Medical
Galt Medical is recalling Drainer Centesis Catheter, Sterile EO, distributed in 19 states. The recall was initiated on 2 May 2018 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-2560-2018
- FDA event ID
- 80021
- Recalling firm
- Galt Medical, Garland, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2018
- FDA classified
- 27 Jul 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 2 May 2018 | Recall initiated by company | |
| 27 Jul 2018 | Classified by FDA | +86 days |
| 8 Aug 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Product as listed by the FDA
1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,
Where it was distributed
U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
CaliforniaFloridaGeorgiaIllinoisKentuckyLouisianaMassachusettsMinnesotaMissouriMississippiNorth CarolinaNew YorkOhioPennsylvaniaPuerto RicoTexasUtahVirginiaWashington
Questions about this recall
Why was it recalled?
The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
Which lots are affected?
Lot #: 1) a) 18037128, 18057123; b) 18026062, 18026063; c) 18050076, 18092077; 2) a) 17303409, 17313728, 17324971, 17324972, 17340309, 17340310, 17355684; b) 17303412, 17311642, 17335910, 17340312, 17340314, 17355685, 17355686, 17355687; c) 17311643, 17314335, 17349257, 18026356, 18033604, 18047978, 18096513, 18110747; d) 17314337, 17321338, 17352567, 18005181
Where was it sold?
U.S.: MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico; OUS: Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, Korea
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.
Other products in this recall event
7 other products · FDA event 80021| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centeze Centesis Catheter recalled by Galt Medical | Galt Medical | Other | 19 states | |
| CLASS II | Tearaway Introducers recalled by Galt Medical | Galt Medical | Other | 19 states | |
| CLASS II | Elite HV Introducer recalled by Galt Medical | Galt Medical | Other | 19 states | |
| CLASS II | TVS LPA, Sterile EO recalled by Galt Medical | Galt Medical | Other | 19 states | |
| CLASS II | Elite HV, Hemostasis Valve Introducer System, Sterile EO recalled | Galt Medical | Other | 19 states | |
| CLASS II | TVS LPA recalled by Galt Medical | Galt Medical | Other | 19 states | |
| CLASS II | Vascular Dilator, Sterile EO recalled by Galt Medical | Galt Medical | Other | 19 states |
More recalls from Galt Medical
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | GALT Centeze Catheter recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
| Device | CLASS II | Introducer Kit- Coaxial Dilator recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
| Device | CLASS II | Introducer Needle recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
| Device | CLASS II | Introducer Kit- Tearaway MicroSlide recalled by Galt Medical | Galt Medical | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |