Clint Pharmaceuticals
26 catalogue numbers from ACL6TG, listed by ICU Medical, Inc, United States, under Anesthesia Conduction Kit. 1 manufacturer in China is registered for this product code.
1manufacturer
26catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | CAZ |
| Device type | Anesthesia Conduction Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5140 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K965017 |
| Record published | 2017-01-13 |
| Record revised | 2025-04-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 30, case of 10, case of 24 |
| Distribution end date | 2019-08-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACL6TG | In distribution | |
| ACL10AT | In distribution | |
| ACL17SPG | In distribution | |
| ACL11SPS | In distribution | |
| ACL7SP | In distribution | |
| ACL14 | In distribution | |
| ACL4EX | In distribution | |
| ACL11CH | In distribution | |
| ACL10SPS | In distribution | |
| ACL6SP45 | In distribution | |
| ACL7SPG | In distribution | |
| ACL10 | In distribution | |
| ACS25Q35F | In distribution | |
| ACL1 | In distribution | |
| ACL5SPS | In distribution | |
| ACS22Q45 | In distribution | |
| ACS22Q35 | In distribution | |
| ACL5SPG | In distribution | |
| ACL10SPG | Withdrawn | |
| ACS22Q554 | Withdrawn | |
| ACS22Q354 | Withdrawn | |
| ACS22QQQ35 | Withdrawn | |
| ACL11RX | Withdrawn | |
| ACL10SPS12 | Withdrawn | |
| ACL11SPS12 | Withdrawn | |
| ACL12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 1,340 |
| Arrow | Teleflex Medical LLC | 508 |
| Halyard | Avanos Medical, Inc. | 422 |
| Avanos | Avanos Medical, Inc. | 315 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 215 |
| Integra® | Integra Pain Management | 181 |
| Epilong | Pajunk Gmbh Medizintechnologie | 79 |
| BD Perisafe, BD Epilor, BD Luer-Lok | Becton, Dickinson AND Company | 44 |
| Temena | Temena GmbH | 44 |
| BD Luer-Lok, BD Glaspak | Becton, Dickinson AND Company | 36 |
| Contiplex® | B. Braun Medical Inc. | 34 |
| Stimulong Sono | Pajunk Gmbh Medizintechnologie | 27 |
Showing 12 of 109. All products under Anesthesia Conduction Kit
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ICU Medical, Inc | 510(k) number | 2025-12-19 | Class II | Under Investigation by firm | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. | 64290 total | |
| Smiths Medical Asd, Inc. | 510(k) number | 2006-10-27 | Not classified | Other | Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch | 540 units | 2012-05-22 |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Smiths Medical Asd, Inc. | 510(k) number | 2005-11-17 | Not classified | Other | Tray may contain holes compromising the sterility of the device | 2012-05-08 | |
| Portex, Inc. | 510(k) number | 2003-10-10 | Not classified | Other | Spinal trays labeled as containing a Whitacre 25g x 3.5′ needle actually contain a Quincke 25g x 3.5′ needle. | 2600 units | 2006-05-02 |
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.