Recall record at a glance
| Official record | Z-1097-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield |
| Report date | Feb 15, 2023 |
| Recall initiation date | Nov 17, 2022 |
| Quantity | 1,419 cases (4,349 units) |
| Location | Northfield, IL, United States |
Official product description
Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK
Why the product was recalled
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: not stated.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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