Device recall: Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801)…
Class II FDA enforcement event 90793. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Cook Incorporated started this device recall on 16 Aug 2022. The firm address in the FDA record is in Bloomington, IN. FDA put the recall in Class II. FDA event 90793 has 24 product records. The first FDA enforcement report date is 5 Oct 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Domestic distribution nationwide. Foreign distribution worldwide.
Recalling firm
Cook Incorporated, Bloomington, IN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
24 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1824-2022 | Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874) | 204 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1825-2022 | Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735) | 488 US, 5 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1826-2022 | Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041) | 43 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1827-2022 | Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095) | 5571 US, 409 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1828-2022 | Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268 | 1,236 US | Class II | Ongoing | 5 Oct 2022 |
| Z-1829-2022 | Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427 | 1,501 US; 380 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1830-2022 | Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077 | 2,748 US; 302 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1831-2022 | Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145 | 150 US, 97 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1832-2022 | Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476 | 58 US; 5 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1833-2022 | Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507… | 9,903 US; 5,185 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1834-2022 | Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18-30 G02261 C-SF-25-40 G01937 TSF-18-260 G00590 C-SF-25-50 G01938 TSF-35-180 G00652 C-SF-18-40 G02255 TSF-25-145 G00617 TSF-32-145 G00638 C-SF-15-50 G02274 TSF-18-145 G00587 TSF-18-50 G00593 TSF-35-145 G00650 TSF-21-145 G00602 THSF-35-180… | 5,669 US; 5,286 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1835-2022 | Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925 | 25 US | Class II | Ongoing | 5 Oct 2022 |
| Z-1836-2022 | Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561 | 42 US | Class II | Ongoing | 5 Oct 2022 |
| Z-1837-2022 | Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542 | 56 US; 1033 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1838-2022 | Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607 | 277 US; 138 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1839-2022 | Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 | 202 US; 11 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1840-2022 | Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866 | 115 US | Class II | Ongoing | 5 Oct 2022 |
| Z-1841-2022 | Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534 | 363 US; 244 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1842-2022 | Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261 | 5041 US; 298 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1843-2022 | Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304 | 149 US | Class II | Ongoing | 5 Oct 2022 |
| Z-1844-2022 | Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898 | 240 US; 108 OUS | Class II | Ongoing | 5 Oct 2022 |
| Z-1845-2022 | Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033 | No distribution (Distribution Center only) | Class II | Ongoing | 5 Oct 2022 |
| Z-1846-2022 | Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678 | No distribution (Distribution Center only) | Class II | Ongoing | 5 Oct 2022 |
| Z-1847-2022 | Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677 | N/A | Class II | Ongoing | 5 Oct 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 24Median of the firm: 2
- Events of the firm on the register
- 16
Other events of the firm
Official channels
- FDA enforcement report Z-1824-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 90793. https://recallregister.com/fda/ii/90793/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Domestic distribution nationwide. Foreign distribution worldwide.
- What quantity of product is in FDA event 90793?
- The event has 24 product records. The first record gives this quantity:
204 OUS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.