Z-0954-2025Class II
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model...
Sklar Corporation / initiated 2024-12-03 / Open, Classified / root cause: packaging
Sklar Instruments began a recall of ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5"... on . FDA classified it as Class II and gives the reason as "Reports of various packaging issues that may result in a breach of the sterile barrier". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0954-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Sklar Corporation
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECONO STERILE OLSEN-HEGAR NH DEL 5.5 STER 25, Model Number 96-2356A; 5) ECONO STERILE OLSEN-HEGAR NH SMO 5.5 STER 25, Model Number 96-2358A; 6) ECONO STERILE WEBSTER NH SERR JAW5.25" CS/25, Model Number 96-2417; 7) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/50, Model Number 96-2580; 8) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581; 9) ECONO STERILE BAUMGARTNER NH 5.5" STER CS/25, Model Number 96-2581A; 10) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583; 11) ECONO STERILE DERF NH SERR 4 3/4" STERL CS25, Model Number 96-2583A; 12) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585; 13) ECONO STERILE HALSEY NH SMOOTH 5" STERL CS25, Model Number 96-2585A; 14) ECONO STERILE WEBSTER NH SMO 5.25" STER CS50, Model Number 96-2586; 15) ECONO STERILE WEBSTER NH SMO 5.25" STER CS25, Model Number 96-2587; 16) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/50, Model Number 96-2590; 17) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591; 18) ECONO STERILE CRILE-WOOD NH 6" STERILE CS/25, Model Number 96-2591A; 19) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/50, Model Number 96-2594; 20) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595; 21) ECONO STERILE MAYO-HEGAR NH 6" STERILE CS/25, Model Number 96-2595A; 22) ECONO STERILE MAYO-HEGAR NH 5" STERILE CS/25, Model Number 96-2599; 23) ECONO STERILE WEBSTER NH SMO 5 1/4 STRL C100, Model Number 96-2659; 24) ECONO STERILE MAYO-HEGAR NH 7" STERILE CS/50, Model Number 96-2710; 25) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711; 26) ECONO STERILE MAYO-HEGAR NH 8" STERL CS25, Model Number 96-2711A; 27) ECONO STERILE MAYO-HEGAR NH 8" STERILE CS/50, Model Number 96-2712; 28) ECONO STERILE WEBSTER NH FINE 5.25" STER 25, Model Number 96-2740A; 29) ECONO STERILE WEBSTER NH X-FIN LG 5" STER 25, Model Number 96-2741A; 30) ECONO STERILE WEBSTER NH X-FN SMO 5" STER 25, Model Number 96-2742A; 31) ECONO STERILE HALSEY NH SERR TC 5" STER CS25, Model Number 96-2745A; general orthopedic surgery
- Product code
- HXK Holder, Needle; Orthopedic
- Reason for recall
- Reports of various packaging issues that may result in a breach of the sterile barrier.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- On December 3, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Action required: 1. Check your inventory for any affected product lots (see Attachment A). If you have affected product in inventory, discontinue use immediately. 2. Notify Additional Users. If you have further distributed any of the items referenced in this notification, you must notify those downstream customers of this recall. Forward a copy of this letter, along with copies of Attachment A and the Recall Acknowledgement form, for such customers to complete and return to Sklar. 3. Notify Sklar. Please complete the enclosed Recall Acknowledgement form as soon as possible, indicating whether you do or do not have any of the affected products remaining in your inventory and whether you have distributed any of the affected products to downstream customers. Return the form to Sklar by e-mail to [email protected]. 4. Return the affected product. If you do have any of the affected products in inventory, Sklar customer service will contact you to arrange for the affected product to be returned. Sklar will credit its direct customers for returned affected product once it receives the affected product back. Sklar Instruments is committed to providing high quality, safe, and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have experienced an adverse event associated with any of these products, please contact us and/or report the event to FDA s MedWatch Adverse Event Reporting program online.
- Quantity in commerce
- 41850 units
- Distribution
- Domestic: Nationwide Distribution
- Product codes and lots
- 1) 96-2352A, UDI/DI 50649111488151, Lot codes: HSI; 2) 96-2353, UDI/DI 50649111397996, Lot codes: SK-130; 3) 96-2355A, UDI/DI 50649111488144, Lot codes: HSI; 4) 96-2356A, UDI/DI 50649111488137, Lot codes: HSI; 5) 96-2358A, UDI/DI 50649111488168, Lot codes: HSI; 6) 96-2417, UDI/DI 50649111440272, Lot codes: SK-130; 7) 96-2580, UDI/DI 50649111062696, Lot codes: FSF12, FSF13, FSF17, FSF20, FSF22, FSF24, FSF26, FSS19; 8) 96-2581, UDI/DI 50649111062955, Lot codes: FSF12, FSF17, FSF20, FSF22; 9) 96-2581A, UDI/DI 50649111487796, Lot codes: SK-112; 10) 96-2583, UDI/DI 50649111063266, Lot codes: SK-130; 11) 96-2583A, UDI/DI 50649111487833, Lot codes: SK-112; 12) 96-2585, UDI/DI 50649111063549, Lot codes: FSF12, FSF14, FSF21; 13) 96-2585A, UDI/DI 50649111487895, Lot codes: SK-112; 14) 96-2586, UDI/DI 50649111063877, Lot codes: SK-130; 15) 96-2587, UDI/DI 50649111064010, Lot codes: SK-130, SK-131; 16) 96-2590, UDI/DI 50649111064577, Lot codes: FSF12, FSF17, FSF22; 17) 96-2591, UDI/DI 50649111064799, Lot codes: FSF12, FSF13, FSF20, FSF26; 18) 96-2591A, UDI/DI 50649111487826, Lot codes: SK-112; 19) 96-2594, UDI/DI 50649111065437, Lot codes: FSF7, FSF12, FSF16, FSF17, FSF18; 20) 96-2595, UDI/DI 50649111065642, Lot codes: FSF5, FSF16, FSF18, FSF19, FSF20; 21) 96-2595A, UDI/DI 50649111488052, Lot codes: SK-112; 22) 96-2599, UDI/DI 50649111066342, Lot codes: FSF6, FSF21; 23) 96-2659, UDI/DI 50649111077669, Lot codes: SK-130; 24) 96-2710, UDI/DI 50649111085664, Lot codes: FSF13; 25) 96-2711, UDI/DI 50649111478886, Lot codes: FSF10; 26) 96-2711A, UDI/DI 50649111488069, Lot codes: SK-112; 27) 96-2712, UDI/DI 50649111085916, Lot codes: FSF10; 28) 96-2740A, UDI/DI 50649111488274, Lot codes: SK-112; 29) 96-2741A, UDI/DI 50649111488281, Lot codes: SK-112; 30) 96-2742A, UDI/DI 50649111488298, Lot codes: SK-112; 31) 96-2745A, UDI/DI 50649111487949, Lot codes: 60440.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0925-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0926-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0927-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0928-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0929-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0930-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0931-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0932-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0933-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0934-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0935-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0936-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0937-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0938-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0939-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0940-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0941-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0942-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0943-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0944-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0945-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0946-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0947-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0948-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0949-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0950-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0951-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0952-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0953-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0954-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.