Z-0098-2019Class II

Colpo-Pneumo Occluder, Part CPO-6

Name: Z-0098-2019 Colpo-Pneumo Occluder, Part CPO-6
Creator: CooperSurgical, Inc.
Published: 2018-09-04
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2018-09-04 / Terminated / root cause: packaging

FDA source

CooperSurgical, Inc. began a recall of Colpo-Pneumo Occluder, Part CPO-6 on 2018-09-04. FDA classified it as Class II and gives the reason as "The seal of the sterile pouch may be compromised, thereby increasing the risk of infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0098-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-04
Posted: 2018-10-11
Terminated: 2020-05-27
Recalling firm: CooperSurgical, Inc.
Product: Colpo-Pneumo Occluder, Part CPO-6
Product code: HEW Culdoscope (And Accessories)
Reason for recall: The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Root cause tag: packaging
FDA root cause: Other
Action: Urgent Medical Device Recall Notification letters dated 9/4/18 were distributed to customers. The letters instruct customers do the following: Please be advised that CooperSurgical has initiated a corrective action to inspect finished goods in inventory for potential unsealed pouches. If any product from the 26 lots is in your possession and has a green label affixed to the outer display box as displayed below, it is not affected by this recall action. A product is acceptable for use if it is visually confirmed that the pouchs seal is intact. As indicated in the Directions for Use (DFU), each package should be handled with care and inspected for damage, including the seal area before use. Inspect the package contents and the sterile seal along the entire periphery of the package. Refer to the table below for examples of acceptable / not acceptable conditions. Please discontinue use of the product with any packaging irregularities, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Once the form is completed and returned to CooperSurgical, a Customer Service Representative will contact you with a Return Merchandise Authorization (RMA) number and provide instructions for the return of product to CooperSurgical. If replacements are requested, a replacement order will be placed immediately. If you do not have affected stock, please complete and return the enclosed Acknowledgement and Receipt Form, in order for us to document receipt of this letter.
Quantity in commerce: 32538
Distribution: The products were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to the following foreign countries: Canada, Columbia, Czech Republic, Germany, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Russian Federation, Singapore, Slovenia, South Korea, Spain, Switzerland, UAE, and UK.
Product codes and lots: Lots 244131, 244132, 244670, 244671, 244887, 244888, 244889, 244890, 245228, 245325, 245326, 245327, 245613, 245614, 245615, 245976, 245977, 245978, 245979, 246810, 246811, 247262, 247608, 24 7609, 247610, & 248112

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0098-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-11

Product code HEW

K954311Class IIKoh Colpotomizer SystemCooperSurgical, Inc. / cleared 1996-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)