Curlin
Curlin 6000 Lithium Ion Battery Pack
5manufacturers in China registered for this device type
8catalogue numbers in this listing
2510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Zyno Electric & Machinery Ltd, Shanghai | Shanghai | Shanghai | Contract manufacturer | 1 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Zevex, Inc., United States |
|---|---|
| FDA product code | FRN |
| Device type | Pump, Infusion |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2021-11-03 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Distribution end date | 2021-11-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Curlin AC Adapter, International | In distribution | |
| Curlin Bolus Cord | In distribution | |
| Battery Pack | In distribution | |
| Curlin AC Adapter | In distribution | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn | |
| 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Port Access Infusion SET | Sb-Kawasumi Laboratories, Inc. | 76 |
| Cadd | ICU Medical, Inc | 56 |
| Flow Control Tubing | GO Medical Industries PTY. Ltd. | 39 |
| Curlin Administration Set | Zevex, Inc. | 30 |
| ambIT | Summit Medical Products, Inc. | 27 |
| Beeline motIV | Rex Pj Tech LLC | 24 |
| RMS Precision Flow Rate TubingTM | Repro-Med Systems, Inc. | 24 |
| Medfusion | ICU Medical, Inc | 24 |
| Volumat™ Line | Fresenius Kabi AB | 24 |
| Outlook® | B. Braun Medical Inc. | 21 |
| Alaris | CareFusion 303, Inc | 19 |
| Alpha Source Battery | Alpha Source Inc. | 17 |
Showing 12 of 191. All products under Pump, Infusion
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K242660 | 2024-10-03 |
| K232793 | 2024-05-17 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-02-27 | Class II | Nonconforming Material/Component | Administration sets leaked at the filter. | 569/20-set caess | 2021-04-28 |
| 2019-02-27 | Class II | Nonconforming Material/Component | Administration sets leaked at the filter. | 756/20-set cases | 2021-04-28 |
| 2015-12-23 | Class II | Process control | Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over deliv | 11,472 | 2017-02-21 |
| 2012-09-26 | Class II | Process control | This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with | 12,000 sets | 2013-04-05 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 204 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 520 (never distributed – all in Moog’s possession) | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 11,628 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 2012-07-26 | |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 77 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 814 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 1480 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 104 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 932 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 204 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 204 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 406 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 2652 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 2 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 125 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 816 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 18,494 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 4341 | 2012-07-26 |
| 2012-03-20 | Not classified | Nonconforming Material/Component | Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use. | 693 | 2012-07-26 |
| 2011-02-28 | Not classified | Software design | Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. | 918 units | 2012-08-06 |
| 2011-02-28 | Not classified | Software design | Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. | 11,902 units | 2012-08-06 |
| 2011-02-28 | Not classified | Software design | Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. | 3,407 units | 2012-08-06 |
| 2011-02-28 | Not classified | Software design | Infusion pumps may exhibit false error codes which render the device inoperable until a recovery process is performed. | 2079 units | 2012-08-06 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 8,080 units | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 178,820 units (US), 220 units (INTL) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 840 units | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 4500 Units (US),. 140 units (INTL) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 12,400 units (US) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 179,460 units (US), 960 units (INTL) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 2,020 | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 51,400 units (US), 1600 units (INTL) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 1320 units (US) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 17,120 units (US), 240 units (INTL) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 185,360 units (US), 140 units (INTL) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 4,060 units (US) | 2011-09-27 |
| 2011-01-24 | Not classified | Process control | Defect in tubing may trigger false Air-In-Line warning. | 222,900 units (US) | 2011-09-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.