Z-1925-2020 Class II Ongoing
FDA device recall Z-1925-2020 was initiated by Stryker Corporation on January 7, 2020 and is designated Class II. Reason for recall: Sterile drapes packaged in an unsealed pouch. The recall status is ongoing. Affected quantity: 26,298 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- January 7, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,298 units
Product Description
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Reason for Recall
Sterile drapes packaged in an unsealed pouch.
Distribution Pattern
US - Nationwide & Puerto Rico OUS - Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, South Korea, Australia, Chile, China, Germany, France, United Kingdom, Hong Kong, India, Italy, Singapore, Thailand, Romania, Belgium, Sweden, Switzerland, Austria, Malaysia, Finland, Denmark, Israel, Qatar, Kazakhstan, Turkey, Czech Republic, Greece, Russia, Poland, Ireland, Philippines, and New Zealand.
Code Information
Impacted Lot Numbers for HH2000 - 1703011, 1703021, 1703031, 1703041, 1703051, 1703061, 1703071, 1703081, 1703091, 1703101, 1703111, 1703121, 1703131, 1703141, 1703151, 1703161, 1703171, 1703181, 1703191, 1703201, 1703211, 1703221, 1703231, 1703241, 1703251, 1703261, 1703271, 1703281, 1703291, 1703301, 1703311, 1704011, 1704021, 1704031, 1704041, 1704051, 1704061, 1704071, 1704081, 1704091, 1704101, 1704111, 1704121, 1704131, 1704141, 1704151, 1704161, 1704171, 1704181, 1704191, 1704201, 1704211, 1704221, 1704231, 1704241, 1704251, 1704261, 1704271, 1704281, 1704291, 1704301, 1705011, 1705021, 1705031, 1705041, 1705051, 1705061, 1705071, 1705081, 1705091, 1705101, 1705111, 1705121, 1705131, 1705141, 1705151, 1705161, 1705171, 1705181, 1705191, 1705201, 1705211, 1705221, 1705231, 1705241, 1705251, 1705261, 1705271, 1705281, 1705291, 1705301, 1705311, 1706011, 1706021, 1706031, 1706041, 1706051, 1706061, 1706071, 1706081, 1706091, 1706101, 1706111, 1706121, 1706131, 1706141, 1706151, 1706161, 1706171, 1706181, 1706191, 1706201, 1706211, 1706221, 1706231, 1706241, 1706251, 1706261, 1706271, 1706281, 1706291, 1706301, 1707011, 1707021, 1707031, 1707041, 1707051, 1707061, 1707071, 1707081, 1707091, 1707101, 1707111, 1707121, 1707131, 1707141, 1707151, 1707161, 1707171, 1707181, 1707191, 1707201, 1707211, 1707221, 1708221, 1709221, 1710191, 1710201, 1710211, 1710221, 1711191, 1711201, 1711211, 1711221, 1711231, 1712021, 1712041, 1712051, 1712061, 1712071, 1712081, 1712091, 1712111, 1712121, 1712131, 1712141, 1712151, 1712161, 1712181, 1712271, 1712281, 1712291, 1712301, 1801031, 1801111, 1805251, 1805261, 1805271, 1805281, 1805291, 1805301, 1805311, 1806011, 1806021, 1806041, 1806051, 1806061, 1806071, 1806091, 1806111, 1806201, 1806211, 1807031, 1807061, 1807071, 1807091, 1807251, 1807261, 1807271, 1808171, 1808181, 1808201, 1808221, 1808231, 1808241, 1808301, 1808311, 1809011, 1809021, 1809031, 1810041, 1810051, 1810061, 1812051, 1812151, 1902231, 1902241, 1902251, 1902261, 1902271, 1902281, 1903011, 1903021, 1903031, 1903181, 1903191, 1903201, 1903211, 1903221, 1903271, 1903281, 1904231, 1904241, 1904251, 1904291, 1905141, 1905151, 1905161, 1905171, 1905211, 1905221, 1905231, 1905241, 1905251, 1906241, 1906251, 1906271, 1906281, 1906291, 1907011, 1907221, 1907231, 1907241, 1907251, 1907261, 1907271, 1907311, 1908011, 1908021, 1908031, 1908051, 1908061, 1908071, 1908081, 1908091, 1908151 HH9006 Spy-Phi Pack Impacted Lot Numbers - 1701x, 1702x, 1703x, 1704x, 1705x, 1706x, 1707x, 1708x, 1709x, 1710x, 1711x, 1712x, 1801x, 1802x, 1803x, 1804x, 1805x, 1806x, 1807x, 1808x, 1809x, 1810x, 1811x, 1812x, 1901x, 1902x, 1903x, 1904x, 1905x, 1906x, 1907x, 1908x, 1909x, 19103. Where x is any alpha numeric character.