McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visua
FDA device recall Z-1824-2015 · posted 2015-06-22 · Terminated
Recall details
- Recalling firm
- CooperSurgical, Inc.
- Reason for recall
- Small sized specula were incorrectly packaged in printed bags for the medium sized speculum
- Action taken
- 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.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- HIB
- Quantity affected
- 9400 units
- Distribution
- Nationwide Distribution including IL, FL, GA, MA, MO, TX, and WA.
- Date initiated
- 2015-04-13
- Date posted
- 2015-06-22
- Date terminated
- 2016-02-05
- Location
- Trumbull, CT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAGINAL SPECULUM - DISPOSABLE (K841909) | Galenica Enterprises, Inc. | 1984-07-31 |