Z-1070-2023Class II
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-11-17 / Open, Classified / root cause: design
MEDLINE INDUSTRIES, LP - Northfield began a recall of Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL on . FDA classified it as Class II and gives the reason as "Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1070-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
- Product code
- OFX General Purpose Dental Tray
- Reason for recall
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
- Quantity in commerce
- 174 cases (750 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Product codes and lots
- a. ORAL SURGERY PACK-LF, Item Number: DYNJ20491N, Case UDI/GTIN: 40195327024582, Unit UDI/GTIN: 10195327024581, Lot Number: 22IDA002; b. EXTRACTION PACK, Item Number: DYNJ49329F, Case UDI/GTIN: 40195327059638, Unit UDI/GTIN: 10195327059637, Lot Number: 22HBR730; c. ORAL SURGERY PACK, Item Number: DYNJ52404G, Case UDI/GTIN: 40195327222612, Unit UDI/GTIN: 10195327222611, Lot Number: 22IDA539,22HDB737; d. DENTAL MINOR PACK, Item Number: DYNJ83140, Case UDI/GTIN: 40195327232956, Unit UDI/GTIN: 10195327232955, Lot Number: 22JBN386; e. ORAL, Item Number: DYNJ902377G, Case UDI/GTIN: 40195327224746, Unit UDI/GTIN: 10195327224745, Lot Number: 22KBG529,22JBO834;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1060-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1061-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1062-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1063-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1064-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1065-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1066-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1067-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1068-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1069-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1070-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1071-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1072-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1073-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1074-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1075-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1076-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1077-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1078-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1079-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1080-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1081-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1082-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1083-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1084-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1085-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1086-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1087-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1088-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1089-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1090-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1091-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1092-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1093-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1094-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1095-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1096-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1097-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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