Z-2292-2023Class 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. ART LINE KIT ICH OR, Model Number: ART900; b... 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-2292-2023
- 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. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART995; d. ARTERIAL LINE INSERTION KIT, Model Number: ART775B; e. ARTERIAL LINE KIT W/O CATHETER, Model Number: ART890A; f. ARTERIAL LINE START KIT, Model Number: ART1160; g. ARTERIAL LINE START KIT W/O CATH, Model Number: P42453; h. ARTERIAL LINE TRAY W/O CATHETER, Model Number: ART1180; i. RADIAL ARTERIAL LINE KIT, Model Number: ART1070A
- Product code
- CBT Arterial Blood Sampling 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
- 4,900 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: ART900; UPC Number: 10653160342540. b. Model Number: DT22570; UPC Number: 10653160343851. c. Model Number: ART995; UPC Number: 10193489190502. d. Model Number: ART775B; UPC Number: 10653160353560. e. Model Number: ART890A; UPC Number: 10653160356677. f. Model Number: ART1160; UPC Number: 10653160355762. g. Model Number: P42453; UPC Number: 10653160323792. h. Model Number: ART1180; UPC Number: 10653160355472. i. Model Number: ART1070A. UPC Number: 10653160358329.
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 |
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