Food, drugs, devices › Cook Inc.
Device recall: Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages.
FDA enforcement event 77167 is a device recall by Cook Inc. of Bloomington, IN, initiated 1 May 2017 and classified Class II, with 6 product records.
FDA defines Class II as 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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 26 Mar 2019. Initiation: voluntary: firm initiated. Cook Inc. has 61 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cook Inc., Bloomington, IN.
Reason for recall
"COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products."
Distribution
"Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2310-2017 | Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy. | 327 lots, 364 units | Class II | Terminated | 14 Jun 2017 |
| Z-2311-2017 | Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy. | 327 lots | Class II | Terminated | 14 Jun 2017 |
| Z-2312-2017 | Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy. | 327 lots | Class II | Terminated | 14 Jun 2017 |
| Z-2313-2017 | Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to… | 327 Lots, 725 units | Class II | Terminated | 14 Jun 2017 |
| Z-2314-2017 | LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures. | 327 lots, 288 units | Class II | Terminated | 14 Jun 2017 |
| Z-2315-2017 | LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures. | 327 lots, 335 units | Class II | Terminated | 14 Jun 2017 |
Context
Other enforcement events for Cook Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Mar 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.