Recall Z-1824-2015 ยท HIB Speculum, Vaginal, Nonmetal
CooperSurgical, Inc.
McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
| Date | Jun 22, 2015 (initiated Apr 13, 2015) |
| Status | Terminated |
| Reason | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum |
| Root cause | Packaging change control |
| Action | CooperSurgical sent an Urget Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to discontinue use, discard, or return the affected to product to Cooper Surgical. Customers were asked to complete the attached Acknowledgment and Receipt Form for replacement. Customers with questions were instructed to call 203-601-5200. |
| Quantity | 9400 units |
| Distribution | Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K841909 | VAGINAL SPECULUM - DISPOSABLE Galenica Enterprises, Inc., Jul 31, 1984 |