FDA Device recall Z-2560-2018
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, St…
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of 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, St… by Galt Medical, citing the products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2560-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-02 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Galt Medical |
| Distribution | CA, FL, GA, IL, KY, LA, MA, MN, MO, MS, NC, NY, OH, PA, PR, TX, UT, VA, WA |
Product
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,
Reason
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.
Identifiers
| code_info | Lot #: 1) a) 18037128, 18057123; b) 18026062, 18026063; c) 18050076, 18092077; 2) a) 17303409, 17313728, 17324971,…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2560-2018%22
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