Z-2333-2023Class 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. CHN OR DAVINCI PROSTATE, 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-2333-2023
- 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. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;
- Product code
- OHD Gynecological Laparoscopic 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
- 7,462 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: DYNJ902540N, UPC Number: 019348991666. b. Model Number: DYNJ63257B, UPC Number: 019348942817. c. Model Number: DYNJ0771979C, UPC Number: 019348940069. d. Model Number: DYNJ906578F, UPC Number: 019532728963. e. Model Number: DYNJ906579F, UPC Number: 019532728964. f. Model Number: DYNJ906616G, UPC Number: 019532728947. g. Model Number: DYNJ905824I, UPC Number: 019532728972. h. Model Number: DYNJ906578D, UPC Number: 019532721712. i. Model Number: DYNJ906579A, UPC Number: 019348942214; Model Number: DYNJ906579B, UPC Number: 019348986153; Model Number: DYNJ906579D, UPC Number: 019532721713; Model Number: DYNJ906579F, UPC Number: 019532728964. j. Model Number: DYNJ906616A, UPC Number: 019348942213; Model Number: DYNJ906616B, UPC Number: 019348986167; Model Number: DYNJ906616C, UPC Number: 019532702358; Model Number: DYNJ906616D, UPC Number: 019532714503; Model Number: DYNJ906616F, UPC Number: 019532721728. k. Model Number: DYNJ0752001K, UPC Number: 019348978302. l. Model Number: DYNJ904343D, UPC Number: 019348991389; Model Number: DYNJ904343F, UPC Number: 019532714890. m. Model Number: DYNJ60009B, UPC Number: 019532705797; Model Number: DYNJ60009C, UPC Number: 019532720643. n. Model Number: DYNJ904250G, UPC Number: 019532717379. o. Model Number: DYNJ905826G, UPC Number: 019532728973. p. Model Number: DYNJ904254G, UPC Number: 019532700342; Model Number: DYNJ904254I, UPC Number: 019532704701. q. Model Number: DYNJ905824F, UPC Number: 019532702351; Model Number: DYNJ905824G, UPC Number: 019532721704; Model Number: DYNJ905824I, UPC Number: 019532728972. r. Model Number: DYNJ64027A, UPC Number: 019532705798; Model Number: DYNJ64027B, UPC Number: 019532720644.
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.