MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PAC…
Reason for recall
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKUDYNJ902149JUDI-DI 10888277771512113 affected lots23JDB68323JDC54824ADB78324HDA822DYNJ44805M101953275068724019532750687323JBI747
+105 more
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
What the firm is doing
On April 22, 2025, the firm notified customers of the recall through letters titled Immediate Action Required Voluntary Medical Device Recall. Customers were instructed to identify and quarantine all affected product on hand. Customers are to submit a response form to the recalling firm. Upon receipt of the response firm, Medline will provide the customer with over-labels to place on affected inventory, which will include instructions for staff to remove and discard the affected component prior to using the kit. Distributors should notify downstream customers/accounts of this recall. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1811-2025
- FDA device classification · OJHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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