Z-2293-2023Class II
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-15 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number... on . FDA classified it as Class II and gives the reason as "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2293-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C; c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864; d. BLOCK KIT, Model Number: DYNJRA1893; e. DR LEWIS US TRAY, Model Number: DYNJRA1998; f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109; g. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739A; h. NERVE BLOCK INSERTION, Model Number: DYNJRA2027; i. NERVE BLOCK PREP TRAY, Model Number: DYNJRA1837; j. NERVE BLOCK TRAY, Model Number: DYNJRA1878, DYNJRA1900; k. NERVE PERIPHERAL PACK, Model Number: DYNJRA2055; l. PAIN BLOCK TRAY, Model Number: DYNJRA0827A; m. PAIN PREP TRAY W/PROBE COVER, Model Numbers: DYNJRA0881, DYNJRA1847, DYNJRA1975; n. PAIN PREP W/ PROBE COVER TRAY, Model Number: DYNJRA2028; o. PAIN PREP W/PROBE COVER TRAY, Model Number: PAIN1762; p. PAIN TRAY, Model Number: DYNJRA1603; q. PERIPHERAL NERVE CATHETER KT, Model Number: PAIN1560; r. PREOP NERVE BLOCK TRAY, Model Number: DYNJRA2040; s. PREP TRAY, Model Number: DYNJRA1498A; t. SINGLE SHOT BLOCK, Model Number: DYNJRA0961B; u. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA2077; v. TAP BLOCK, Model Number: DYNJRA1823; w. TRAY ULTRASOUND BLOCK 20G X 4, Model Number: DYNJRA9044; x. TRAY 18G CPNB 20G STYLETED, Model Number: DYNJRA9040; y. ULTRASOUND TRAY, Model Number: DYNJRA2022; z. US TPI KIT, Model Number: DYNJRA1945
- Product code
- OFT Spinal Epidural Anesthesia Kit
- Reason for recall
- Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
- Quantity in commerce
- 29,277 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
- Product codes and lots
- All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJRA1869; UPC Number: 019532701881. b. Model Number: DYNJRA0949C; UPC Number: 019348966504. c. Model Number: DYNJRA1864; UPC Number: 019348926312. d. Model Number: DYNJRA1893; UPC Number: 019532706282. e. Model Number: DYNJRA1998; UPC Number: 019532719429. f. Model Number: DYNJRA1978, UPC Number: 019348926312; Model Number: DYNJRA1978A, UPC Number: 019532732040; Model Number: SAMPA0109, UPC Number: 019532709698. g. Model Number: DYNJRA1739A; UPC Number: 019348992495. h. Model Number: DYNJRA2027; UPC Number: 019532722522. i. Model Number: DYNJRA1837. UPC Number: 019348997671. j. Model Number: DYNJRA1878, UPC Number: 019532704037; Model Number: DYNJRA1900, UPC Number: 019532708225. k. Model Number: DYNJRA2055, UPC Number: 019532725516. l. Model Number: DYNJRA0827A, UPC Number: 019348921446. m. Model Number: DYNJRA0881, UPC Number: 019348926312; Model Number: DYNJRA1847, UPC Number: 019348999366; Model Number: DYNJRA1975, UPC Number: 019532716324. n. Model Number: DYNJRA2028, UPC Number: 019348926312. o. Model Number: PAIN1762, UPC Number: 019348996209. p. Model Number: DYNJRA1603, UPC Number: 019348929900. q. Model Number: PAIN1560, UPC Number: 019348921538. r. Model Number: DYNJRA2040, UPC Number: 019532724369. s. Model Number: DYNJRA1498A, UPC Number: 019532712905. t. Model Number: DYNJRA0961B, UPC Number: 019532726771. u. Model Number: DYNJRA2077, UPC Number: 019532727891. v. Model Number: DYNJRA1823, UPC Number: 019348996188. w. Model Number: DYNJRA9044, UPC Number: 019348988811. x. Model Number: DYNJRA9040, UPC Number: 019348983051. y. Model Number: DYNJRA2022, UPC Number: 019532721816. z. Model Number: DYNJRA1945, UPC Number: 019532713305.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2290-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2291-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2292-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2293-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2294-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2295-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2296-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2297-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2298-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2299-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2300-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2301-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2302-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2303-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2304-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2305-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2306-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2307-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2308-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2309-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2310-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2311-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2312-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2313-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2314-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2315-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2316-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2317-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2318-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2319-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2320-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2321-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2322-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2323-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2324-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2325-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2326-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2327-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2328-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2329-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2330-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2331-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2332-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2333-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2334-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2335-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2336-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2337-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2338-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2339-2023 | 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.